Statutory Instruments of the Scottish Parliament

SCOTTISH STATUTORY INSTRUMENTS

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2000 No. 453
AGRICULTURE
30101 The Feeding Stuffs (Scotland) Regulations 2000


	Made	28th December 2000
	Laid before the Scottish Parliament	3rd January 2001
	Coming into force	31st January 2001



ARRANGEMENT OF REGULATIONS


1.	Citation, commencement and extent

2.	Interpretation

3.	Prescribed material

4.	Matters required or permitted to be contained in a statutory statement or otherwise declared

5.	Forms of statutory statement

6.	Register of marks

7.	Limits of variation

8.	Assigned meanings

9.	Manner of packaging and sealing compound feeding stuffs, additives and premixtures

10.	Control of feed materials

11.	Applications for Community authorisation of additives and of new uses for additives

12.	Confidential information relating to additives

13.	Control of additives in feeding stuffs

14.	Control of feeding stuffs and feed materials containing undesirable substances

15.	Control of compound feeding stuffs containing prohibited materials

16.	Control of certain protein sources

17.	Control of the iron content of milk replacer feeds

18.	Control of ash insoluble in hydrochloric acid in compound feeding stuffs

19.	Control of feeding stuffs intended for particular nutritional purposes, and supplementary provisions relating to statutory statement

20.	Modification of the Agriculture Act 1970 in relation to all feeding stuffs

21.	Modification of the Agriculture Act 1970 in relation to imported feeding stuffs

22.	Exemption from these Regulations

23.	Further exemption from these Regulations

24.	Enforcement of provisions made under section 2(2) of the European Communities Act 1972

25.	Modification of section 74A(3) of the Agriculture Act 1970

26.	Revocations

27.	Modification of the Feeding Stuffs (Sampling and Analysis) Regulations 1999

28.	Modification of the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999

29.	Modification of the Feeding Stuffs (Enforcement) Regulations 1999


SCHEDULES


1.

Methods of calculating the energy value of compound feeds




2.

Control of feed materials




3.

Permitted additives and provisions relating to their use




4.

Contents of the statutory statement or other declaration (except for additives and premixtures not contained in feeding stuffs)




5.

Contents of the statutory statement (for additives and premixtures not contained in feeding stuffs)




6.

Limits of variation




7.

Prescribed limits for undesirable substances




8.

Control of certain protein sources




9.

Permitted feeding stuffs for particular nutritional purposes and provisions relating to their use




10.

Categories of feed materials for use in relation to compound feeding stuffs


The Scottish Ministers, in exercise of the powers conferred by sections 66(1), 68(1) and (1A), 69(1), (3), (6) and (7), 70(1), 74(1), 74A, 77(4), 78(6) and 84 of the Agriculture Act 1970[1] and, after consultation as required by section 84(1) of the said Act with the persons or organisations appearing to represent the interests concerned, and in exercise of the powers conferred by section 2(2) of the European Communities Act 1972[2], and of all other powers enabling them in that behalf hereby make the following Regulations:

Citation, commencement and extent
     1.  - (1) These Regulations may be cited as the Feeding Stuffs (Scotland) Regulations 2000 and shall come into force on 31st January 2001.

    (2) These Regulations extend to Scotland only.

Interpretation
     2.  - (1) In these Regulations-


"the Act" means the Agriculture Act 1970;
"additive" means a substance or preparation used in animal nutrition in order to-
(a) affect favourably the characteristics of feed materials, compound feeding stuffs or animal products;

(b) satisfy the nutritional needs of animals or improve animal production (in particular by affecting the gastro-intestinal flora or the digestibility of feeding stuffs);

(c) introduce into nutrition elements conducive to obtaining particular nutritional objectives or to meeting the nutritional needs of animals at a particular time; or

(d) prevent or reduce the harmful effects caused by animal excretions or improve the animal environment,



but excludes everything excluded from coverage of the Additives Directive by Article 1.2 and 1.3 thereof;



"the Additives Directive" means Council Directive 70/524/EEC concerning additives in feeding stuffs[3];
"the Agency" means the Food Standards Agency;
"ash" means the matter which results from the treatment of a feeding stuff in accordance with the appropriate procedure set out in the method of analysis for ash specified in Point 5 of the Annex to Directive 71/250/EEC[4];
"authorised", in relation to any additive, or the name of any additive, save in the expressions "authorised intermediate product" and "authorised medicated premix", and subject to paragraph (2) below, means authorised in or, as the case may be, under, the Additives Directive, and "authorisation" shall be construed accordingly;
"authorised intermediate product" and "authorised medicated premix" have the meanings given in regulation 2(1) of the Medicated Feedingstuffs Regulations 1998[5];
"the Certain Products Directive" means Council Directive 82/471/EEC concerning certain products used in animal nutrition[6];
"complementary feeding stuff", subject to regulation 14(10)(a), means a compound feeding stuff which has a high content of certain substances and which, by reason of its composition, is sufficient for a daily ration only if it is used in combination with other feeding stuffs;
"complete feeding stuff", subject to regulation 14(10)(a), means a compound feeding stuff which, by reason of its composition, is sufficient to ensure a daily ration;
"compound feeding stuff", subject to regulation 14(10)(a), means a mixture of feeding stuffs;
"the Compound Feeding Stuffs Directive" means Council Directive 79/373/EEC on the marketing of compound feedingstuffs[7];
"daily ration" means the average total quantity of feeding stuff, expressed on a 12% moisture basis, required daily by an animal of a given kind, age group and level of production in order to satisfy all its nutritional needs;
"dossier" means a dossier compiled in accordance with the relevant provisions of the Dossiers Directive and which includes-
(a) an identification note (containing where applicable the information specified in Article 9o.1 of the Additives Directive);

(b) any monograph supplied pursuant to Article 9n.3 of the Additives Directive; and

(c) in the case of an additive to which Article 7a of the Additives Directive applies, the documents referred to in the indented paragraphs of the first paragraph of that Article;


"the Dossiers Directive" means Council Directive 87/153/EEC fixing guidelines for the assessment of additives in animal nutrition[8];
"EC approved Article 2.2(d) establishment" means an establishment listed on a register of approved establishments, maintained by a competent authority in a member State, in implementation of Article 5 of the Establishments Directive, as an establishment on which a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of that Directive, may be manufactured with a view to putting it into circulation;
"EC approved Article 2.2(f) establishment" means an establishment listed on a register of approved establishments, maintained by a competent authority in a member State, in implementation of Article 5 of the Establishments Directive, as an establishment on which a compound feeding stuff, of any kind the production of which is regulated by Article 2.2(f) of that Directive, may be produced for the exclusive requirements of the producer's holding;
"EC permitted Article 2.2(d) establishment" means an establishment located in a member State (other than an EC approved Article 2.2(d) establishment or an establishment which a competent authority in the member State has declined to approve as such an establishment) if-
(a) a compound feeding stuff, of any kind the manufacture of which is regulated by Article 2.2(d) of the Establishments Directive, was being manufactured on the establishment, with a view to putting it into circulation, on 1st April 1998; and

(b) before 1st September 1998, an application (which is pending) in respect of the establishment, was made to a competent authority in the member State, in accordance with any requirements in the member State for the making of such applications, to approve the establishment, pursuant to the Establishments Directive, as an establishment on which a compound feeding stuff of any such kind may be manufactured with a view to putting it into circulation;


"EC permitted Article 2.2(f) establishment" means an establishment located in a member State (other than an EC approved Article 2.2(f) establishment or an establishment which a competent authority in the member State has declined to approve as such an establishment) if-
(a) a compound feeding stuff, of any kind the production of which is regulated by Article 2.2(f) of the Establishments Directive, was being produced on the establishment, for the exclusive requirements of the producer's holding, on 1st April 1998; and

(b) before 1st September 1998, an application (which is pending) in respect of the establishment, was made to a competent authority in the member State, in accordance with any requirements in the member State for the making of such applications, to approve the establishment, pursuant to the Establishments Directive, as an establishment on which a compound feeding stuff of any such kind may be produced for the exclusive requirements of the producer's holding;


"EEA Agreement" means the Agreement on the European Economic Area signed at Oporto on 2nd May 1992 as adjusted by the Protocol signed at Brussels on 17th March 1993[9];
"EEA State" means a State which is a Contracting Party to the EEA Agreement;
"energy value" means the energy value of a feeding stuff calculated in accordance with the relevant method specified in Schedule 1;
"establishment" has the meaning given by Article 1.3(b) of the Establishments Directive;
"the Establishments Directive" means Council Directive 95/69/EC which laid down the conditions and arrangements for approving and registering certain establishments and intermediaries operating in the animal feed sector and which amended 70/524/EEC, 74/63/EEC, 79/373/EEC and 82/471/EEC[10];
"fat" means the extract obtained following the treatment of a feeding stuff in accordance with the appropriate procedure set out in the method of analysis for oils and fats specified in Part IV of the Annex to Directive 71/393/EEC[11];
"feeding stuff", subject to regulation 14(10)(a), has the meaning attributed to it by section 66(1) as modified by regulation 20(1)(a);
"feeding stuff intended for a particular nutritional purpose" means a compound feeding stuff, the composition or method of manufacture of which distinguishes it from other feeding stuffs and from the type of products covered by the Medicated Feedingstuffs Directive, and in respect of which any indication is given that it is intended for a particular nutritional purpose;
"feed material", subject to regulation 14(10)(b), means-
(a) any product of vegetable or animal origin, in its natural state, (whether fresh or preserved);

(b) any product derived from such a product by industrial processing; or

(c) any organic or inorganic substance,



specified in Parts II or III of Schedule 2 (whether or not containing any additive) and for use in oral feeding to pet animals or farmed creatures, directly as such, or after processing, in the preparation of a compound feeding stuff or as a carrier of a premixture;



materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 93/74/EEC and repealing Directive 77/101/EEC[12];
"fibre" means the organic matter calculated following the treatment of a feeding stuff in accordance with the procedure set out in the method of analysis for fibre specified in Point 3 of Annex 1 to Directive 73/46/EEC[13];
"identification note" has the same meaning as in the Additives Directive;
"intermediary" has the meaning given by Article 1.3(c) of the Establishments Directive;
"mammalian meat and bone meal" has the meaning given in Article 4(1) of the Bovine Spongiform Encephalopathy (No. 2) Order 1996[14];
"the Medicated Feedingstuffs Directive" means Council Directive 90/167/EEC laying down the conditions governing the preparation, placing on the market and use of medicated feedingstuffs in the Community[15];
"member State" means a member State other than the United Kingdom;
"MFS prescription" has the meaning given in regulation 2(1) of the Medicated Feedingstuffs Regulations 1998;
"micro-organism" has the meaning given by Article 2(aa) of the Additives Directive;
"milk replacer feed" means a compound feeding stuff administered in dry form, or after reconstitution with a given quantity of liquid, for feeding young animals as a supplement to, or substitute for, post-colostral milk or for feeding calves intended for slaughter;
"mineral feeding stuff" means a complementary feeding stuff which is composed mainly of minerals and which contains at least 40% by weight of ash;
"minimum storage life" means, in relation to a compound feeding stuff, the date until which, under proper storage conditions, that feeding stuff retains its specific properties;
"molassed feeding stuff" means a complementary feeding stuff prepared from molasses and which contains at least 14% by weight of total sugar expressed as sucrose;
"moisture" means water and other volatile material determined in accordance with the procedure set out in the method of analysis for moisture specified in Part I of the Annex to Directive 71/393/EEC[16];
"monograph" has the same meaning as in the Additives Directive;
"name", in relation to any additive specified in any of Parts I to VIII of the Table to Schedule 3, means the name specified for that additive in that Table, and, in relation to any other additive means, its authorised name;
"national list" means the list of establishments published in London by the Agency, for the purposes of Article 6.1 of the Establishments Directive;
"oil" means the extract obtained following the treatment of a feeding stuff in accordance with the appropriate procedure set out in the method of analysis for oils and fats specified in Part IV of the Annex to Directive 71/393/EEC;
"particular nutritional purpose" means the purpose of satisfying any nutritional requirement of pet animals or productive livestock, the process of assimilation or absorption of which, or the metabolism of which, may be temporarily impaired, or is temporarily or permanently impaired, and which may therefore benefit from ingestion of a feeding stuff capable of achieving that purpose;
"pet animal" has the same meaning as in the Additives Directive;
"pet food" means a feeding stuff for pet animals and "compound pet food" shall be construed accordingly;
"premixture" means a mixture of additives, or a mixture of one or more additives with substances used as carriers, intended for the manufacture of feeding stuffs;
"protein", except in paragraphs 12(2), 13, 28(2) and 29 of Part I of Schedule 4, and subject to paragraph (3) below, means the matter obtained as a result of treatment of a feeding stuff in accordance with the procedure set out in the method of analysis for protein specified in Point 2 of Annex 1 to Directive 72/199/EEC[17];
"protein equivalent of biuret, diureidoisobutane, urea or urea phosphate" in relation to an amount of biuret, diureidoisobutane, urea and urea phosphate nitrogen, means that amount multiplied by 6.25;
"put into circulation" has the same meaning as in the Feed Materials Directive but, in regulation 14(3), (4) and (7), also means import into Scotland from a country which is neither an EEA State nor part of an EEA State;
"registered veterinarian" has the same meaning as in the Medicated Feedingstuffs Directive;
"starch" means the matter obtained as the result of treatment of a feeding stuff in accordance with the procedure set out in the method of analysis for starch specified in Point 1 of Annex 1 to Directive 72/199/EEC[18];
"third country" means a country other than a member State or the United Kingdom;
"UK approved Article 2.2(d) establishment", "UK approved Article 2.2(f) establishment", "UK permitted Article 2.2(d) establishment" and "UK permitted Article 2.2(f) establishment" have, subject to regulation 14(5), the meanings respectively given to them by regulation 3 of the Feedingstuffs (Establishments and Intermediaries) Regulations 1999[19], as read with regulation 2(4) of those Regulations;
"zootechnical additive" means an additive belonging to one or more of the groups of additives specified in Part I of Annex C to the Additives Directive;
"zootechnical feeding stuff" means a feeding stuff that contains a zootechnical additive or zootechnical premixture; and
"zootechnical premixture" means a premixture that contains a zootechnical additive.

    (2) The additives appearing in the Section headed "Radionuclide Binders", and as numbers 3 and 4 in the Section headed "Micro-organisms", in the Annex to Commission Regulation (EC) No. 2785/98[20], shall be deemed for the purposes of these Regulations to be "authorised" within the meaning of that term as defined in paragraph (1) above.

    (3) For the purposes of paragraphs 12(1) and 28(1) of Part I of Schedule 4, "protein" has the meaning given to it by article 4(1) of the Bovine Spongiform Encephalopathy (No.2) Order 1996.

    (4) In these Regulations, "botanical purity" shall be construed in accordance with paragraph 2 of Section II of Part A of the Annex to the Feed Materials Directive.

    (5) Any reference in these Regulations to a numbered regulation or Schedule shall, unless the context otherwise requires, be construed as a reference to the regulation or Schedule bearing that number in these Regulations.

    (6) Any reference in these Regulations to a numbered section shall, unless the reference is to a section of a specified Act, be construed as a reference to the section bearing that number in the Act.

    (7) Any reference in these Regulations to a European Community Directive or Regulation shall be construed as a reference to that Directive or, as the case may be, Regulation, as amended as at the date these Regulations are made.

Prescribed material
     3.  - (1) These Regulations apply to material of the following description, that is to say any material usable as a feeding stuff, and any material usable as a feed material, premixture or additive in such a feeding stuff.

    (2) The description in paragraph (1) above is a prescribed description for the purposes of sections 68(1) and 69(1); and in these Regulations material so described is referred to as the "prescribed material".

    (3) In the application of section 68 with respect to the prescribed material, subsection (2) shall be disregarded.

Matters required or permitted to be contained in a statutory statement or otherwise declared
     4. The particulars, information and instructions required, and the particulars, information and instructions permitted, to be contained in a statutory statement or, as the case may be, otherwise declared, shall be as specified in, and shall comply with, the provisions of Schedule 4 (save in respect of additives and premixtures not contained in feeding stuffs) and Schedule 5 (in respect of additives and premixtures not contained in feeding stuffs).

Forms of statutory statement
     5.  - (1) Subject to the provisions relating to small quantities of feeding stuffs in the second paragraph of Article 16.6 of the Additives Directive, and Article 5 of the Compound Feeding Stuffs Directive, and paragraph (2) below, the statutory statement-



(a) in the case of any prescribed material delivered in a package or other container, shall-


(i) take the form of a label attached to that package or container; or

(ii) be clearly marked directly thereon; and



(b) in the case of such material delivered in bulk, shall take the form of a document relating to and accompanying each consignment.



    (2) In the case of any feed material sold in a quantity not exceeding 10 kg, and supplied directly to the final user thereof, the statutory statement may be provided in the form of a notice in writing.

    (3) The particulars, information and instructions required or permitted to be contained in the statutory statement shall-



(a) be clearly separate from any other information;

(b) subject to paragraphs (5) and (6) below, be in English; and

(c) be legible and indelible.



    (4) For the purposes of section 69 (marking of material prepared for sale), prescribed material which is contained in a package or other container shall be labelled or marked in the manner prescribed in relation to such material in paragraph (1) or, where applicable, (2), above, and such material in bulk shall be marked by the display in as close proximity to the material as may be practicable of a document relating thereto.

    (5) In the case of any compound feeding stuff or feed material which is intended for export to a member State, the statutory statement shall be in one or more official Community languages, as determined by that member State.

    (6) In the case of any feeding stuff, not being a zootechnical feeding stuff, which is intended for export to an EEA State which is not a member State, the statutory statement shall comply with the requirements of Article 18 of the Additives Directive as if the EEA State were a member State.

Register of marks
     6.  - (1) As respects any feed material, the matters required by section 69(1) to be marked on that material may be denoted by a mark, the meaning of which can be ascertained by reference to a register kept in accordance with this regulation.

    (2) In the case of any compound feeding stuff, not being of a standard formulation on general sale by the seller concerned, which is specially manufactured or mixed to the order of a purchaser-



(a) there shall be an indication in a document, label or notice, which is readily apparent and unequivocally associated with the material, of the type of feeding stuff, and of the name or trade name, and of the address or registered office, of the manufacturer; and

(b) the other matters required by section 69(1) to be marked on the material may be denoted by a mark, the meaning of which can be ascertained by reference to a register kept in accordance with this regulation.



    (3) The register shall show those matters to which the mark relates, being matters required to be contained in a statutory statement relating to the material to which the mark relates, and the date of entry of those particulars in the register, and entries relating to material of a kind mentioned in paragraph (2) above shall include the name and address of the purchaser, the date of the order and the amount ordered.

    (4) The register shall be kept as a separate record in book form, marked on the outside "Register of marks under section 69(6) of the Agriculture Act 1970" and shall be kept on the premises where the material is held for the purpose of selling it in the course of trade for use as a feeding stuff, save that, if the material is not in the premises of the person who has the material for sale, the register shall be kept on those premises.

    (5) The period for which the register is to be preserved in accordance with section 69(7) shall be six months, commencing on the first day on which none of the materials referred to in the register remains on the premises, for sale as aforesaid.

    (6) The register shall be kept by the seller concerned.

Limits of variation
     7.  - (1) In the application of section 74 with respect to the prescribed material, the limits of variation mentioned in subsection (1) shall, in relation to any mis-statement in a statutory statement, document or mark, as to the nature, substance or quality of a feeding stuff or, as the case may be, feed material, where the mis-statement relates to-



(a) any analytical constituent specified in the first column of-


(i) Part A of Schedule 6 (where the feeding stuff is a compound feeding stuff not intended for pets);

(ii) Part B of Schedule 6 (where the feeding stuff is a compound pet food); or

(iii) Part C of Schedule 6 (in the case of a feed material);



(b) any vitamin or trace element specified in the first column of Part D of that Schedule, or

(c) the energy value of any feeding stuff specified in the first column of Part E of that Schedule,



be as set out with respect to that constituent or, as the case may be, vitamin, trace element or feeding stuff, in the corresponding entry in the second column of the relevant Part of that Schedule.

    (2) Particulars with respect to any material which are contained in a statutory statement, or in any document, or which are marked on, or denoted by a mark on, the material, shall not, for the purposes of Part IV of the Act or of these Regulations, be treated as false by reason of any mis statement therein as to the nature, substance or quality of the material, if-



(a) the material was first sold, or otherwise put into circulation, in a member State;

(b) the mis-statement did not, at the time of putting into circulation, exceed any limits of variation prescribed in relation thereto in that member State; and

(c) any such limits were in accordance with any applicable European Community Directive.



Assigned meanings
     8. In the application of section 70 with respect to the prescribed material, there shall be assigned to the expressions "complementary feeding stuff", "complete feeding stuff", "compound feeding stuff", "feeding stuff", "milk replacer feed", "mineral feeding stuff" and "molassed feeding stuff" in each case the meaning given by regulation 2(1) to the expression concerned.

Manner of packaging and sealing compound feeding stuffs, additives and premixtures
     9.  - (1) Subject to paragraphs (2) and (3) below, no person shall sell a compound feeding stuff, or any additive or premixture, unless it is in a bag or container, and that bag or container is sealed in such a way that, when the bag or container is opened, the seal is damaged and cannot be re-used.

    (2) Compound feeding stuffs may be sold in bulk, in unsealed bags or in unsealed containers, in the case of-



(a) deliveries between producers or sellers of compound feeding stuffs;

(b) deliveries from producers of compound feeding stuffs to packaging enterprises;

(c) compound feeding stuffs obtained by mixing grain or whole fruit;

(d) blocks or licks;

(e) small quantities not exceeding 50 kg in weight, which are intended for the final user and are taken directly from a bag or container which, before opening, complied with the sealing provision in paragraph (1) above.



    (3) Compound feeding stuffs may be sold in bulk, in unsealed containers, but not in unsealed bags, in the case of-



(a) direct deliveries from the producer to the final user;

(b) molassed feeding stuffs consisting of less than three feed materials;

(c) pelleted feeding stuffs.



Control of feed materials
     10.  - (1) No person shall put into circulation any feed material of a description specified in column (3) of Part II of Schedule 2, under a name other than that specified in the corresponding entry in column (2) of that Part.

    (2) No person shall put into circulation any feed material of a description specified in column (1) of Part III of Schedule 2, except under a name or description, or a name and description (other than one specified in that column or in column (2) of Part II of that Schedule) sufficiently specific to indicate the nature of the material.

    (3) No person shall-



(a) put into circulation any feed material of a description specified in column (3) of Part II of Schedule 2, and which has a name specified in the corresponding entry in column (2) of that Part which includes a common name or term specified in column (4) of Part I of that Schedule; or

(b) sell, or have in possession with a view to sale, any compound feeding stuff containing any such feed material,



unless, in either case, the feed material was prepared by the process specified, in relation to the common name or term, in column (2), and described in column (3), of Part I of that Schedule.

    (4) No person shall put into circulation any feed material, or sell, or have in possession with a view to sale, any compound feeding stuff containing any feed material, unless-



(a) in the case of any feed material of a description specified in column (3) of Part II of Schedule 2-


(i) the botanical purity by weight of the feed material is not less than the percentage (if any) specified in relation to it in column (3) of Part II of that Schedule or, if none is specified, is not less than 95%; and

(ii) the feed material complies with the requirements of paragraph 1 of Section II of Part A of the Annex to the Feed Materials Directive; and



(b) in the case of any feed material of a description specified in column (1) of Part III of that Schedule-



(i) the botanical purity by weight of the feed material is not less than 95%; and

(ii) the feed material complies with the requirements of paragraph 1 of Section II as aforesaid.



    (5) No person shall use any feed material to bind another feed material, if the quantity of the feed material so used exceeds 3% of the total weight of the feed material bound.

    (6) Without prejudice to sections 73 and 73A, no person shall import into Scotland from any country which is neither a member State nor another part of the United Kingdom, supply (otherwise than on sale) or have in possession with a view to so supplying, any feed material, unless it is wholesome, and is not deleterious or dangerous to farmed creatures, to pet animals or, through consumption of the products of any animal fed with the feed material, to human beings.

    (7) No person shall put into circulation any feed material in a manner likely to mislead.

    (8) In paragraph 4(a) above "description" shall be taken to exclude any botanical purity requirement.

Applications for Community authorisation of additives and of new uses for additives
     11.  - (1) Any person resident, or having a place of business in Scotland who wishes the United Kingdom to act as the rapporteur in connection with-



(a) an application for the Community authorisation of an additive which is not a zootechnical additive; or

(b) an application for the Community authorisation of a new use of an already authorised additive which is not a zootechnical additive,



may submit to the Agency an application for the Community authorisation of the additive or the new use of the additive, as the case may be, and a dossier relating to the additive, or the new use, as the case may be.

    (2) Where documentation is submitted to the Agency pursuant to paragraph (1) above, it shall-



(a) forward it to the Commission; and

(b) forward a copy of it to each member State,



in accordance with Article 4.3 of the Additives Directive, if it is satisfied as specified in paragraph (3) below.

    (3) The Agency is satisfied in accordance with this paragraph if it is satisfied that-



(a) the dossier submitted pursuant to paragraph (1) above has been compiled in accordance with the applicable provisions of the Dossiers Directive; and

(b) the additive to which the dossier relates, or the new use to which it relates, as the case may be, appears to meet the conditions laid down in Article 3a of the Additives Directive.



    (4) If, in relation to a dossier submitted pursuant to paragraph (1) above, the Agency is not satisfied about both of the matters specified in paragraph (3) above, it shall reject the documentation, or postpone taking the action specified in paragraph (2) above in relation to the documentation, until such time as it is satisfied about both of those matters.

    (5) Where the Agency rejects documentation submitted to it pursuant to paragraph (1) above, or postpones taking the action specified in paragraph (2) above in relation to it, it shall inform the Commission, the applicant and each member State of the rejection or postponement, and shall notify them of the reasons for the rejection or postponement.

    (6) If requested to do so by the Commission, the Agency shall forward a copy of all or part of a dossier relating to any additive for which an application has been submitted to it pursuant to paragraph (1) above, to each member of the Scientific Committee for Animal Nutrition.

Confidential information relating to additives
     12.  - (1) Subject to paragraphs (2) and (3) below, no person shall publish or disclose any confidential information obtained by that person in the performance of functions under regulation 11, without the previous consent in writing of the person who, in accordance with that regulation, has made an application for Community authorisation of, or, as the case may be, for a new use of, the additive concerned.

    (2) Nothing in paragraph (1) above shall restrict the publication or disclosure of such information for the purpose of the exercise of functions under regulation 11.

    (3) Nothing in paragraph (1) above shall prevent the publication or disclosure of confidential information of a type specified in Article 7.2 of the Additives Directive.

    (4) In this regulation, "confidential information" means information of the type specified in Article 7.1 of the Additives Directive.

    (5) A publication or disclosure in contravention of paragraph (1) above shall be punishable as if it were a disclosure prohibited by section 83.

Control of additives in feeding stuffs
     13.  - (1) No person shall use an additive for the purpose of animal nutrition unless any incorporation thereof in a feeding stuff accords with paragraph (2) to (4) below.

    (2) Subject to regulation 23 and paragraph (8) below, no person shall carry out a relevant activity in relation to an additive, unless-



(a) where the additive is not contained in a feeding stuff-


(i) the additive is-


(aa) permitted to be contained in material intended for use as a feeding stuff pursuant to paragraph 5(1) of Schedule 3; or

(bb) specified in any of Parts I to VIII of the Table to Schedule 3[21]; or



(ii) the relevant activity relates to an additive authorised under any European Community Regulation specified in Part IX of that Table;



(b) where the additive is contained in a feeding stuff, it is covered by sub-paragraph (a) above and, where applicable, the feeding stuff or, as the case may be, the relevant activity, complies with the relevant requirements specified in Schedule 3 or, as the case may be, with the relevant conditions required to be observed for compliance with the European Community Regulation concerned.



    (3) In paragraph (2) above, "relevant activity", in relation to an additive, means any one or more of the following:-



(a) the putting into circulation for use as a feeding stuff of any material containing the additive;

(b) the use as a feeding stuff of any material containing the additive;

(c) the putting of the additive into circulation, for incorporation in a feeding stuff;

(d) the incorporation of the additive in a feeding stuff.



    (4) Without prejudice to paragraph (2) above, no person shall incorporate any additive into a feed material, unless-



(a) (where the additive is listed in any of Parts I to VIII of the Table to Schedule 3) the expression "all feeding stuffs" appears, opposite to that additive, whether or not accompanied by qualifying words, in the column headed "Conditions" in the Part concerned;

(b) (where the additive is otherwise authorised) it is indicated in the European Community Regulation concerned that such incorporation is permitted; or

(c) the additive is permitted to be contained in material pursuant to paragraph 5(1) of that Schedule.



    (5) Paragraphs (1) to (4) above shall not apply to any added substance which is-



(a) for use in accordance with an MFS prescription issued by a registered veterinarian, pursuant to regulation 29 of the Medicated Feedingstuffs Regulations 1998[22];

(b) an authorised medicated premix;

(c) an authorised intermediate product; or

(d) a zootechnical additive.



    (6) Subject to paragraph (8) below, no person shall put into circulation, for use as a feeding stuff, any complementary feeding stuff which, when diluted as specified by the manufacturer for feeding to animals, contains any additive specified in any of Parts I to VIII of the Table to Schedule 3, or which is authorised by any European Community Regulation specified in Part IX of that Table, at a level exceeding that specified for that additive in the Part concerned or, as the case may be, in the European Community Regulation, in relation to complete feeding stuffs.

    (7) No person shall-



(a) mix in a premixture or feeding stuff, with an additive which is not a zootechnical additive, another additive which is not a zootechnical additive, unless such mixing is in accordance with Article 9q2 of the Additives Directive; or

(b) mix a micro-organism with a zootechnical additive, unless such mixture is permitted as specified in Article 9q4 of the Additives Directive.



    (8) Paragraph (2) above, in so far as it regulates "putting into circulation", and paragraph (6) above, shall not apply in relation to any additive which is excluded from the application of the Additives Directive by Article 22 thereof.

    (9) No person shall use as a feeding stuff any material containing an additive (not being one permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of, the Table to Schedule 3, or which is otherwise authorised) which is deleterious to farmed creatures, to pet animals, to human beings or to the environment.

Control of feeding stuffs and feed materials containing undesirable substances
     14.  - (1) No person shall sell, or have in possession with a view to sale, for use as a feeding stuff, or use as a feeding stuff, any material specified in column 2 of Part I of Schedule 7, which contains any substance specified in column 1 of that Part in excess of the level specified in relation thereto in column 3 thereof.

    (2) No person shall sell, or have in possession with a view to sale, for use as a feeding stuff, or use as a feeding stuff, any complementary feeding stuff if-



(a) when it is diluted as specified by the manufacturer for feeding to animals, it contains any substance specified in column 1 of Part I of Schedule 7, in excess of the level specified for that substance in column 3 of that Part in relation to complete feeding stuffs; and

(b) there is no provision relating to any complementary feeding stuff in the corresponding entry in column 2 of that Part.



    (3) No person shall put into circulation any feed material specified in column 2 of Chapter A of Part II of Schedule 7, which contains any substance specified in column 1 of that Part in excess of the level specified in relation thereto in column 3 thereof.

    (4) Without prejudice to paragraph (3) above, and subject to paragraph (5) below, no person shall put into circulation any feed material specified in column 2 of Chapter A of Part II of Schedule 7, or in column 2 of Chapter B of that Part, which contains any substance specified in relation to the material in question in the corresponding entry in column 1 of the Chapter in question, in excess of the level specified in column 3 of Part I of that Schedule in relation to the corresponding feed material unless-



(a) the feed material put into circulation-


(i) is intended for use only on-


(aa) a UK approved or permitted Article 2.2(d) establishment;

(bb) a UK approved or permitted Article 2.2(f) establishment;

(cc) an EC approved or permitted Article 2.2(d) establishment; or

(dd) an EC approved or permitted Article 2.2(f) establishment; and



(ii) is accompanied by a document stating-



(aa) that it is intended for use by such establishments,

(bb) that it may not be fed unprocessed to livestock, and

(cc) the amount of the specified substance contained in the material; or



(b) the feed material is intended for supply by way of export to a third country.



    (5) For the purposes of paragraph (4) above, no UK or EC establishment shall be considered an approved establishment unless-



(a) in the case of a UK establishment, it is included in the most recently published national list (if any);

(b) in the case of an EC establishment, it is included in the most recently published list (if any) equivalent in the member State concerned to the national list.



    (6) No person shall mix with any feeding stuff or feed material, any feed material specified in column 2 of Chapter A of Part II of Schedule 7, if the feed material so specified contains any substance specified in the corresponding entry in column 1 of that Part in excess of the level specified in relation thereto in column 3 thereof.

    (7) No person shall put into circulation any feed material unless it is-



(a) sound and genuine; and

(b) of merchantable quality.



    (8) For the purposes of paragraph (7) above, and without prejudice to the provisions of paragraph (3) above, a feed material is not sound, genuine and of merchantable quality if (were it to be incorporated into any compound feeding stuff specified in column 2 of Part I of Schedule 7) the level of any substance specified in column 1 of that Part, and contained in the feed material, would exceed the level specified for that substance in column 3 of that Part in relation to the compound feeding stuff in question.

    (9) Where a person has or has had in the possession or control of that person, for the purposes of a trade or business, any feeding stuff or feed material and becomes aware-



(a) in the case of a feeding stuff, that it does not comply with any requirement of paragraphs (1) or (2) above; or

(b) in the case of a feed material, that it does not comply with any requirement of paragraphs (3), (4), (7) or (8) above,



that person shall immediately notify the Agency, and an inspector appointed under section 67(3) by the authority which, by virtue of section 67(2), has the duty to enforce Part IV of the Act in relation to the feeding stuff or feed material in question.

    (10) For the purposes of the foregoing provisions of this regulation-



(a) "feeding stuff" means-


(i) a product of vegetable or animal origin in its natural state (whether fresh or preserved);

(ii) a product derived from the industrial processing of such a product; or

(iii) an organic or inorganic substance, used singly or in a mixture,



whether or not containing additives, for oral feeding to pet animals, to farmed creatures or to animals living freely in the wild, and "complementary feeding stuff", "complete feeding stuff" and "compound feeding stuff" shall be construed accordingly; and

(b) "feed material" means a product or substance within the definition of "feed materials" in Article 2(b) of Council Directive 1999/29/EC on undesirable substances and products in animal nutrition[23].



Control of compound feeding stuffs containing prohibited materials
     15.  - (1) No person shall sell, or have in possession with a view to sale, for use as a compound feeding stuff, or use as a compound feeding stuff, any material which contains-



(a) faeces, urine or separated digestive tract contents resulting from the emptying or removal of the digestive tract, irrespective of any form of treatment or admixture;

(b) hide treated with tanning substances, including its waste;

(c) seeds or other plant propagating materials which, after harvest, have undergone specific treatment with plant protection products for their intended propagation, or derived by-products;

(d) wood, sawdust or other materials derived from wood treated with wood protection products;

(e) sludge from sewage plants treating waste waters;

(f) solid urban waste, such as household waste;

(g) untreated waste from eating places, except food stuffs of vegetable origin considered unsuitable for human consumption for reasons of freshness; or

(h) packaging and parts of packaging from products used in agriculture or the food industry.



    (2) For the purposes of paragraph (1) above, except sub-paragraph (e), "waste" shall mean material of any applicable category listed in Annex 1 to Council Directive 75/442/EEC[24] on waste, which is discarded or intended or required to be discarded.

Control of certain protein sources
     16.  - (1) Subject to paragraphs (3) and (4) below, no person shall sell, or have in possession with a view to sale, for use as a feeding stuff or as a protein source in a feeding stuff, any material belonging to a product group specified in column 1 of Schedule 8, unless that material-



(a) is named as a permitted product in column 2 of that Schedule; and

(b) complies with all the specifications and requirements contained in and imposed in relation thereto by columns 3 to 6 of that Schedule.



    (2) Subject to paragraph (3) below, no person shall sell, or have in possession with a view to sale, for use as a feeding stuff, or use as a feeding stuff, any product obtained from yeasts of the "Candida" variety cultivated on n-alkanes.

    (3) Paragraphs (1) and (2) above shall not apply in relation to any material or product excluded from application of the Certain Products Directive by Article 16 thereof.

    (4) Paragraph (1) above shall not apply in the circumstances authorised for derogation by Article 3.2 of the Certain Products Directive.

Control of the iron content of milk replacer feeds
     17. No person shall sell, or have in possession with a view to sale, any milk replacer feed intended for calves of up to 70 kilograms live weight, which has an iron content of less than 30 milligrams per kilogram of the complete feeding stuff at a moisture content of 12%.

Control of ash insoluble in hydrochloric acid in compound feeding stuffs
     18.  - (1) No person shall sell, or have in possession with a view to sale-



(a) any compound feeding stuff composed mainly of rice by-products in which the level of ash insoluble in hydrochloric acid exceeds 3.3% of its dry matter; or

(b) subject to paragraph (2) below, any other compound feeding stuff in which the level of ash insoluble in hydrochloric acid exceeds 2.2% of its dry matter.



    (2) Paragraph (1)(b) above shall not apply to the sale of any compound feeding stuff which-



(a) contains permitted mineral binders named or described in Commission Regulation (EC) No. 2439/1999 on the conditions for authorisation of additives belonging to the group "binders, anti-caking agents and coagulants" in feedingstuffs[25];

(b) is a mineral feeding stuff;

(c) contains more than 50% of sugar beet chips or sugar beet pulp; or

(d) is intended for farmed fish and has a fish meal content of more than 15%,



if the level of ash insoluble in hydrochloric acid is declared in the statutory statement as a percentage of the feeding stuff as such.

Control of feeding stuffs intended for particular nutritional purposes, and supplementary provisions relating to statutory statement
     19.  - (1) No person shall sell, or have in possession with a view to sale, any feeding stuff intended for a particular nutritional purpose unless-



(a) the particular nutritional purpose in question is specified in column 1 of Chapter A of Schedule 9;

(b) the feeding stuff possesses the essential nutritional characteristics specified opposite that particular nutritional purpose in column 2 of that Chapter;

(c) the feeding stuff is intended for animals specified opposite that particular nutritional purpose in column 3 of that Chapter;

(d) it is recommended that the feeding stuff be used for a period of time falling within the range specified opposite that particular nutritional purpose in column 5 of that Chapter;

(e) in relation to the feeding stuff, the requirements specified in paragraphs 1, 2 and 8 of Chapter B of Schedule 9 are complied with; and

(f) the composition of the feeding stuff is such that it is capable of achieving the particular nutritional purpose for which it is intended.



    (2) Schedule 10 shall have effect as specified in Schedule 4.

Modification of the Agriculture Act 1970 in relation to all feeding stuffs
     20.  - (1) In the application of section 66 with respect to the prescribed material-



(a) in subsection (1)-


(i) for the definition of "feeding stuff" there shall be substituted the following definition-



" "feeding stuff" means-
(a) a product of vegetable or animal origin in its natural state (whether fresh or preserved);

(b) a product derived from the industrial processing of such a product; or

(c) an organic or inorganic substance, used singly or in a mixture,



whether or not containing additives for oral feeding to pet animals or farmed creatures;";



(ii) for the definition of "pet animal" there shall be substituted the following definition-



""pet animal" has the same meaning as in Council Directive 70/524/EEC concerning additives in feeding stuffs as amended;"; and
(iii) before the definition of "prescribed" there shall be inserted the following definition-



" "premixture" means a mixture of additives, or a mixture of additives with substances used as carriers, intended for the manufacture of feeding stuffs;"; and

(b) in subsection (2), for paragraph (b)[26] there shall be substituted-


" (b) material shall be treated-


(i) as imported or sold for use as a feeding stuff whether it is imported or, as the case may be, sold, to be used by itself, or as an ingredient, additive or premixture in something which is to be so used; and

(ii) as used as a feeding stuff whether it is so used by itself, or as an ingredient, additive or premixture in something which is to be so used.".



    (2) In their application with respect to the prescribed material, in each of sections 73(1) and 73A(1), for the words "animals of any description prescribed for the purpose of the definition of "feeding stuff" in section 66(1) of this Act" there shall be substituted the words "any farmed creatures".

    (3) In the application of section 85 with respect to the prescribed material-



(a) paragraph (a) shall be disregarded in relation to delivery outside the United Kingdom; and

(b) paragraph (b) shall be disregarded.



Modification of the Agriculture Act 1970 in relation to imported feeding stuffs
     21. In the application of section 69(1) with respect to the prescribed material, the words "and in either case before it is removed from the premises," shall be disregarded in relation to feeding stuffs which have been imported.

Exemption from these Regulations
     22. Insofar as provisions of these Regulations implement the Compound Feeding Stuffs Directive, they shall not apply in the circumstances specified in Article 14(c) of that Directive.

Further exemption from these Regulations
     23. The provisions of regulation 13(2) (in so far as they regulate the putting into circulation of additives and material containing additives), and the provisions of regulation 13(7)(a), shall not apply in the circumstances specified in Article 9q5 of the Additives Directive.

Enforcement of provisions made under section 2(2) of the European Communities Act 1972
     24. Insofar as any provision of these Regulations is made under section 2(2) of the European Communities Act 1972, that provision shall be enforced as if it was made under those provisions of Part IV of the Act under which the other provisions of these Regulations are made, and the provisions of that Part of the Act shall apply accordingly.

Modification of section 74A(3) of the Agriculture Act 1970
     25.  - (1) For the purposes of the provisions specified in paragraph (2) below, section 74A(3) shall have effect as if, for the words "regulations under subsection (1) above, or fails to comply with any other provision of the regulations," there were substituted the words "any provision specified in regulation 25(2) of the Feeding Stuffs (Scotland) Regulations 2000".

    (2) The provisions specified for the purposes of paragraph (1) above are regulations 10(1), (2), (3)(a), (4) (in relation to putting into circulation), (6) and (7), 13(3)(a), (c) and (d), (4), (6) and (7) and 14(3), (4), (6), (7) and (9).

Revocations
     26. Except insofar as they made modifications to the Act, the Feeding Stuffs Regulations 1995[27], the Feeding Stuffs (Amendment) Regulations 1996[28], the Feeding Stuffs (Amendment) Regulations 1998[29], the Feeding Stuffs (Amendment) (No. 2) Regulations 1998[30] and the Feeding Stuffs (Amendment) Regulations 1999[31] are hereby revoked.

Modification of the Feeding Stuffs (Sampling and Analysis) Regulations 1999
     27. In the Feeding Stuffs (Sampling and Analysis) Regulations 1999[32]-



(a) paragraph 5(1) of Part II of Schedule 1 shall have effect as if the words "section 76(1)(b) of the Act" read "section 76(7) of the Act, as that section is modified by regulation 10 of the Feeding Stuffs (Enforcement) Regulations 1999"[33];

(b) the references in paragraph 3(e)(ii) of Part I of Schedule 2, and paragraph 11(a) of Part II of Schedule 3, to "the Feeding Stuffs Regulations 1995", shall have effect as if they read "the Feeding Stuffs (Scotland) Regulations 2000"; and

(c) the second entry for Starch (polarimetric method), in Annex I of Part II to Schedule 2, shall have effect as if, for the provisions relating to that entry in columns 2 and 3, there were substituted the following provisions:-



Point 1 of Annex 1 to Directive 72/199/EEC (as replaced entirely by the Annex to Directive 1999/79/EC)(4)

O.J. No. L123, 29.5.72, p.6. (O.J./S.E. 1966-1972 supplement p.74). O.J. No. L209, 7.8.1999, p.23.".

Modification of the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999
     28.  - (1) The provisions of the Feeding Stuffs (Establishments and Intermediaries) Regulations 1999 specified in paragraph (2) below shall have effect as if, after the words "the Feeding Stuffs (Sampling and Analysis) Regulations 1999", wherever they occur, there were added the words ", as amended by the Feedingstuffs (Zootechnical Products) Regulations 1999[34] and as modified by the Feeding Stuffs (Scotland) Regulations 2000,".

    (2) The provisions referred to in paragraph (1) above are regulations 98(8) and (9), 99 and 106(1).

Modification of the Feeding Stuffs (Enforcement) Regulations 1999
     29. In the Feeding Stuffs (Enforcement) Regulations 1999-

(a) in regulation 7(2) and (4), the references to "the Feeding Stuffs Regulations 1995", shall have effect as if they read "the Feeding Stuffs (Scotland) Regulations 2000";

(b) in regulation 8, the reference to the Feeding Stuffs (Sampling and Analysis) Regulations 1999 shall have effect as if it were a reference to those Regulations as amended by the Feedingstuffs (Zootechnical Products) Regulations 1999 and as modified by these Regulations;

(c) section 67 shall have effect for the purpose specified in regulation 7(2) of the Feeding Stuffs (Enforcement) Regulations 1999 as if for subsection (8) there were substituted the following subsection (instead of the subsection substituted by regulation 9 of those Regulations):-

    " (8) If the Scottish Ministers are of the opinion that, in the area of an enforcement authority, the Feeding Stuffs (Scotland) Regulations 2000 or section 73 or 73A of this Act have been-


(a) insufficiently enforced or administered by the authority, or

(b) enforced or administered by it without sufficient regard to the requirements of Council Directive 95/53/EC[35] fixing the principles governing the organisation of official inspections in the field of animal nutrition, as amended by Council Directive 1999/20/EC[36],



they may appoint one or more inspectors to exercise the powers exercisable by inspectors appointed by the authority, and any expenses certified by an inspector appointed by the Scottish Ministers as having been reasonably incurred by that inspector under this subsection shall be repaid on demand by that authority."; and

(d) regulation 10 shall, in so far as it modifies section 76, be read as if, in that section as so modified-


(i) in subsections (8), (9) and (10), the references to the Feeding Stuffs (Sampling and Analysis) Regulations 1999 were references to those Regulations as amended by the Feedingstuffs (Zootechnical Products) Regulations 1999, and as modified by these Regulations; and

(ii) for the references in subsection 17 to the Feeding Stuffs Regulations 1995 there were substituted references to these Regulations.

SUSAN C DEACON
A member of the Scottish Executive

Edinburgh
28th December 2000

"Protein" is determined by the method of analysis for protein specified in Point 2 of Annex 1 to Directive 72/199/EC[37]. For pig feed the results must be corrected to 100% dry matter;

"Oil" is determined by the appropriate procedure set out in the method of analysis for oils and fats specified in Part IV of the annex to Directive 71/393/EEC[38]. In ruminant and pig feeds the result must be corrected to 100% dry matter;

"Starch" is determined by the method of analysis for starch specified in Point 1 of Annex 1 to Directive 72/199/EC[39];

"Sugar (expressed as sucrose)" is determined by the method of analysis for sugar specified in Point 12 of the Annex to Directive 71/250/EEC[40];

"Neutral detergent Cellulase plus Gamanase Digestibility" is determined by the method detailed in the booklet "Prediction of Energy Values of Compound Feeding Stuffs for Farm Animals" (published by the Ministry of Agriculture, Fisheries and Food Publications, London SE99 7JT);

"Ash" is determined by the method of analysis for ash specified in Point 5 of the Annex to Directive 71/250/EEC[41]. The result must be corrected to 100% dry matter;

"Moisture" is determined by the method of analysis for moisture specified in Part I of the Annex to Directive 71/393/EEC[42];

"Fibre" is determined by the method of analysis for fibre specified in Point 3 of Annex 1 to Directive 73/46/EEC[43];

Method of calculating the energy value of compound feeds
     2. The energy value of compound poultry, ruminant and pig feeds and feeding stuffs intended for particular nutritional purposes for cats and dogs shall be calculated in accordance with the relevant formulae set out below, on the basis of the percentages of certain analytical components of the feed. After application of these formulae, the results shall be given to one decimal place.

Poultry feeds: megajoules (MJ) of metabolisable energy (ME), nitrogen corrected, per kilogram of compound feed.

MJ of ME/kg of feed = 0.1551 × % protein + 0.3431 × % oil + 0.1669 × % starch + 0.1301 × % total sugar (expressed as sucrose).

Ruminant feeds: megajoules (MJ) of metabolisable energy (ME) per kilogram of dry matter in the compound feed.

MJ of ME/kg of dry matter = 0.14 × % Neutral detergent Cellulase plus Gamanase Digestibility + 0.25 × % oil.

Pig feeds: megajoules (MJ) of digestible energy (DE) per kilogram of dry matter in the compound feed.

MJ of DE/kg of dry matter = 17.47 + 0.079 × % protein + 0.158 × % oil - 0.331 × % ash - 0.140 Neutral Detergent plus Amylase Fibre.

Feeding stuffs intended for particular nutritional purposes for cats and dogs: megajoules (MJ) of metabolisable energy (ME) per kilogram of compound dog or cat food.

(a) cat and dog foods with the exception of cat foods having a moisture content exceeding 14%: MJ of ME/kg of food = 0.1464 × protein + 0.3556 × % oils and fats + 0.1464 × % nitrogen - free extract;

(b) cat foods having a moisture content exceeding 14%: MJ of ME/kg of cat food = (0.1632 × % protein + 0.3222 × % oils and fats - + 0.1255 × % nitrogen - free extract) - 0.2092;

where in either case the percentage of nitrogen - free extract is calculated by subtracting from 100 the total of the percentages of moisture, ash, protein, oils and fats and fibre.

Where the results of analysis are to be given on a dry matter basis, this may be achieved by analysing either the dried material, or fresh material and correcting for the moisture content.

     8.  - (1) No material shall contain any added preservative other than one named or described in columns 2 and 3 of Chapter A of Part VII, unless the material complies with the conditions (if any) specified in relation thereto in column 4 of that Chapter.

    (2) No material shall contain any added preservative specified in columns 2 and 3 of Chapter B of Part VII which, taking into account any such preservative which is naturally present, exceeds, the maximum content specified in relation thereto in column 5.

    (3) No material shall contain any added preservative specified in columns 2 and 3 of Chapter B of Part VII unless the material is for a species or category of animal listed opposite the preservative in question in column 4 of that Chapter, and is used in accordance with the specifications, if any, laid down in respect of it in columns 5 to 7 thereof.

     9. No material shall contain any acidity regulator, except that material intended for use as a pet food for dogs and cats may contain any of the acidity regulators named in Part VIII.

     10. Unless otherwise stated, any maximum or minimum specified for the content in any feeding stuff of any additive, in the relevant Part of Parts I to VIII, or in the relevant European Community Regulation specified in Part IX[87], is so specified by reference to a complete feeding stuff with a moisture content of 12%.

     11. The second paragraph of Article 9q1 of the Additives Directive shall have effect in relation to any additive covered by a European Community Regulation specified in Part IX.

(a) for trace elements other than copper (if the amount present can be determined by the method of analysis specified in Point 3 of the Annex to Directive 78/633/EEC[100] or by some other valid scientific method), the name of the additive and the total level of the element, whether naturally present or added; and

(b) for vitamins other than vitamins A, D and E, provitamins and substances having a similar chemical effect (if the amount present can be determined by any valid scientific method), the name of the additive, the active substance level, whether naturally present or added, and an indication of the period during which that level will remain present.

     4. Any amount referred to-

(a) in paragraph 2(c), (3)(a) or 3(b) above shall be expressed in milligrams per kilogram; and

(b) in paragraph 2(b) above shall be expressed in million international units per kilogram, international units per kilogram, milligrams per kilogram or micrograms per kilogram, as appropriate.

     5. By way of exception to paragraph 4(a) above, any amount referred to in paragraph 2(c), 3(a) or 3(b) above may be expressed as a percentage by weight, unless the amount is less than 0.1% by weight, in which case it shall be expressed in milligrams per kilogram or micrograms per kilogram, as appropriate.

     6. The particulars required or permitted by paragraphs 2 or 3 above to be included in the statutory statement may be accompanied (in the case of any additive not being an enzyme or a micro-organism) by the trade name or the EC registration number of any additive named therein.

     7. Subject to paragraphs 8 to 11 below, in the case of any feed material which is sold, or otherwise put into circulation, by any person, the following particulars shall be contained in the statutory statement-

(a) in the case of any feed material of a kind specified in column (3) of Part II to Schedule 2-


(i) the corresponding name specified in column (2) of that Part (the inclusion of any word appearing in brackets in that column being optional); and

(ii) the particulars (if any) specified in relation to the feed material in the corresponding entry in column (4) of that Part;



(b) in the case of any feed material of a kind specified in column (1) of Part III to Schedule 2-



(i) its name or description there specified, or a name and description (other than one specified in that column, or in column (2) of Part II to that Schedule) sufficiently specific to indicate the nature of the material, and in conformity with the criteria specified in the Introductory Notes to Part II to that Schedule; and

(ii) the particulars specified in relation to the feed material in the corresponding entry in column (2) of Part III to that Schedule;



(c) in the case of any feed material-



(i) subject to regulation 5(5) as read with Article 6.4 of the Feed Materials Directive and the requirements of Article 8(b) of that Directive, which shall be observed where applicable, the words "feed material";

(ii) the moisture content of the feed material, if it exceeds 14% by weight of the feed material or, where a different percentage is specified in relation to that feed material in Part II or Part III to Schedule 2, if it exceeds that percentage;

(iii) the moisture content of the feed material, where it does not exceed the relevant percentage specified in paragraph (ii) above, but a purchaser requests that the moisture content be declared;

(iv) the level of ash insoluble in hydrochloric acid in the feed material, if that level exceeds 2.2% in the dry matter or, where a different percentage is specified in relation to that feed material in Part II or Part III to Schedule 2, if it exceeds that percentage;

(v) where any other feed material has been used to denature the feed material, the nature and quantity of the other feed material so used;

(vi) where any other feed material has been used to bind the feed material, the nature of the other feed material so used;

(vii) the net quantity of the feed material, expressed in units of mass in the case of any solid feed material and, in the case of any liquid feed material, in units of mass or volume;

(viii) where the feed material is part of a divided batch of feed materials, reference to the original batch; and

(ix) the name or business name, and the address or registered business address, of the person within the European Community responsible for the particulars specified in this sub-paragraph.

     8. Any person established in Scotland who is obligated to give particulars specified in paragraph 7(a)(ii) and (b)(ii) and (c)(ii) to (iv) above shall not be required to do so where-

(a) before the feed material concerned is sold or supplied, the person to whom it is sold or supplied notifies the seller or supplier in writing that those particulars need not be supplied; or

(b) any feed material of animal or vegetable origin, fresh or preserved, and intended for pet animals, is sold or supplied in a quantity not exceeding 10 kg directly to the final user thereof.

     9.  - (1) In the case of any feed material which-

(a) originated in a country other than a member State or the United Kingdom; and

(b) is, for the first time, put into circulation in Scotland and the European Community,

in the circumstances specified in the introductory paragraph of Article 6.2 of the Feed Materials Directive, provisional details of the particulars specified in paragraph 7(a)(ii), (b)(ii) and (c)(ii) to (iv) above may be provided, if the requirements of sub-paragraph (2) below are observed.

    (2) The requirements of this sub-paragraph are observed if-

(a) the person responsible for giving those particulars gives notification, in advance, of the impending arrival of the feed material in Scotland, to an inspector appointed under section 67(3) by the authority which, by virtue of section 67(1), has the duty to enforce Part IV of the Act at the intended place of arrival;

(b) the provisional details are accompanied by the following declaration in bold type-

"

(c) the person responsible as aforesaid provides the final particulars in question to the person to whom the feed material is supplied, and to the inspector referred to in subparagraph (a) above, within 10 days of its arrival in Scotland.

    (3) Where the requirements of sub-paragraph (2) above are observed, it shall be the duty of the inspector concerned to notify the European Commission that, in relation to the feed material concerned, the provisional particulars concerned have been provided, and to inform the Commission of the nature of those particulars.

     10.  - (1) The particulars specified in paragraph 7 above shall not be required in the case of any feed material of animal or vegetable origin, in its natural state, fresh or preserved, and which is not treated with an additive other than any preservative, if the feed material is provided by a farmer producer in Scotland to a breeder-user, who carries on business in the United Kingdom.

    (2) For the purposes of this paragraph, "farmer-producer" and "breeder-user" shall have the same meanings as in the Feed Materials Directive.

     11.  - (1) The particulars specified in paragraph 7(a)(ii), (b)(ii), and (c)(ii) to (vii) above shall not be required in the case of any feed material which is a by-product of vegetable or animal origin derived from agro-industrial processing, and which has a moisture content greater than 50%.

    (2) For the purposes of this paragraph, "agro-industrial processing" shall have the same meaning as in the Feed Materials Directive.

     12.  - (1) Where any person sells, or otherwise puts into circulation, any feed material comprising protein derived from mammalian tissue but containing no mammalian meat and bone meal, and intended for animals other than pet animals, the statutory statement shall contain the declaration specified in subparagraph (2) below.

    (2) The declaration referred to in subparagraph (1) above is-

" This feed material comprises protein derived from mammalian tissue the feeding of which to ruminants is prohibited".

     13. Where any person sells, or otherwise puts into circulation any feed material comprising or containing mammalian meat and bone meal, and intended for animals other than pet animals, the statutory statement shall contain the following declaration-

" This feed material comprises protein derived from mammalian tissue the feeding of which to ruminants, all other categories of farmed creatures and equine animals is prohibited".

     14.  - (1) Subject to sub-paragraph (2) below, in the case of any compound feeding stuff, the following particulars shall be contained in the statutory statement-

(a) the description "complete feeding stuff", "complementary feeding stuff", "mineral feeding stuff", "molassed feeding stuff", "complete milk replacer feed" or "complementary milk replacer feed", as appropriate;

(b) save where the feeding stuff is constituted from no more than three feed materials, and is clearly described by reference to its feed materials, either in the statutory statement or elsewhere on its package, label or container, the species or category of animal for which the feeding stuff is intended, and directions for the proper use of the feeding stuff, indicating the purpose for which it is intended; and

(c) as from 1st April 2001, the approval number allocated, in accordance with Article 5 of the Establishments Directive, to the establishment which manufactured the compound feeding stuff.

    (2) In the case of-

(a) any pet food, the descriptions "complete pet food" and "complementary pet food" may be used instead of "complete feeding stuff" and "complementary feeding stuff" respectively; and

(b) any feeding stuff for pet animals other than dogs or cats, each of the descriptions "complete feeding stuff" and "complementary feeding stuff" may be replaced by either of the descriptions "compound feeding stuff" or "compound pet food", but in such a case the statutory statement shall comply with paragraph 16 below and the provisions relating to complete feeding stuffs in Part II of this Schedule even if it would not otherwise be required to do so.

     15. In the case of any compound feeding stuff, the following particulars shall be declared either in the statutory statement, or elsewhere on the package, label or container (in which case the statutory statement shall indicate where they are to be found) - 

(a) the net quantity, expressed in the case of solid products in units of mass, and in the case of liquid products in units of mass or volume;

(b) the minimum storage life, which shall be expressed-


(i) in the case of microbiologically highly perishable feeding stuffs, by the words "use before…" followed by the appropriate date (day, month and year); and

(ii) in all other cases by the words "best before…" followed by the appropriate date (month and year),



except that, where an expiry date for a period is required to be declared by paragraph 2(b) or 3(b) above, and is earlier than the appropriate date otherwise required by this paragraph, that expiry date shall be used as the appropriate date; and

(c) the batch number if the date of manufacture is not declared.

     16.  - (1) In the case of any compound feeding stuff other than a whole grain mix, the statutory statement-

(a) shall include such declarations of the matters provided for in the columns of Part II of this Schedule as must be included; and

(b) may include such declarations provided for in the columns of Part II of this Schedule as may be included,

for consistency with Article 5 of the Compound Feeding Stuffs Directive.

    (2) In the case of a whole grain mix, the statutory statement may include such of the declarations provided for in the columns of Part II of this Schedule, as may be included for consistency with Article 5 of the Compound Feeding Stuffs Directive.

     17.  - (1) In the case of any compound feeding stuff other than a whole grain mix, the moisture content shall be declared in the statutory statement if it exceeds the following levels-

milk replacer feeds and other compound feeding stuffs with a milk product content exceeding 40%	7%
mineral feeding stuffs containing no organic substances	5%
mineral feeding stuffs containing organic substances	10%
other compound feeding stuffs	14%

    (2) In the case of a whole grain mix, or a compound feeding stuff with a moisture content not exceeding the limits stated in subparagraph (1) above, the moisture content may be declared in the statutory statement.

     18.  - (1) In the case of any compound feeding stuff for dogs or cats, all the feed materials shall be declared in the statutory statement.

    (2) In the case of any compound feeding stuff for pet animals other than dogs and cats, the feed materials may be declared in the statutory statement, and in such case all the feed materials shall be declared.

    (3) Subject to paragraph 26(2) below and paragraph 3 of Chapter B of Schedule 9, feed materials declared in accordance with subparagraph (1) or (2) above shall be declared either-

(a) by their specific names, with an indication of the amount of each feed material; or

(b) by their specific names in descending order by weight; or

(c) by categories, as described in Part I of Schedule 10, in descending order by weight,

and the use of one of those forms of declaration shall preclude the use of either of the others, save-

(i) where the declaration is by categories and any feed material belongs to none of the categories described in Part I of Schedule 10, in which case that feed material, designated by its specific name, shall be listed in order by weight in relation to the categories; or

(ii) where, in the case of any feeding stuff intended for a particular nutritional purpose, paragraph 26(2) below and paragraph 3 of Chapter B of Schedule 9 require the declaration of any feed material by its specific name, in which case any feed material to which those provisions do not apply may be declared by reference to the category to which it belongs.

     19.  - (1) Subject to paragraph 26(2) below and paragraph 3 of Chapter B of Schedule 9, in the case of any compound feeding stuff for animals other than pet animals, all the feed materials shall be declared in the statutory statement in descending order of weight, either by their specific names or by the names of the categories in Part II of Schedule 10 to which they belong.

    (2) The use of either of these forms of declaration shall preclude the use of the other, save-

(i) where the declaration is by categories and any feed material belongs to none of the categories described in Part II of Schedule 10, in which case that feed material, designated by its specific name, shall be listed in order by weight in relation to the categories; or

(ii) where, in the case of any feeding stuff intended for a particular nutritional purpose, paragraph 26(2) below and paragraph 3 of Chapter B of Schedule 9 require the declaration of any feed material by its specific name, in which case any feed material to which those provisions do not apply may be declared by reference to the category to which it belongs.

     20. Where any declaration under paragraphs 18 or 19 above is by specific names, any feed material described in column 3 of Part II of Schedule 2 shall be declared by the corresponding name specified in column 2 of that Part (the inclusion of any word appearing in brackets in that column being optional).

     21. In the case of any compound feeding stuff having a level of ash insoluble in hydrochloric acid not exceeding the relevant level specified in regulation 18(1)(a) or, as the case may be, (b), that level may be declared in the statutory statement as a percentage of the feeding stuff as such.

     22. In the case of any compound feeding stuff, the following particulars may be included in the statutory statement-

(a) if the manufacturer is not the person responsible for the labelling particulars, the name or business name and the address or registered business address of the manufacturer;

(b) an indication of the physical condition of the feeding stuff or the specific processing it has undergone; and

(c) the date of manufacture, expressed as follows-

"

     23.  - (1) In the case of any complementary feeding stuff which contains any additive in excess of the maximum content in relation to complete feeding stuffs specified for that additive in the relevant Part of Parts I to VIII of the Table to Schedule 3 or, as the case may be, in the relevant European Community Regulation specified in Part IX of that Table, and which is not covered by Article 22 of the Additives Directive, the instructions for use in the statutory statement shall state, according to the species and age of the animal, the maximum quantity in grams or kilograms of the feeding stuff which, under these Regulations, may be given per animal per day, and shall be so formulated that, when they are correctly followed, the final content of the additive in relation to complete feeding stuffs does not exceed the maximum so specified in relation to them.

    (2) Sub-paragraph (1) above shall not apply to any products delivered to manufacturers of compound feeding stuffs or to their suppliers.

     24.  - (1) In the particulars required or permitted by paragraphs 15 to 19 and 21 above to be set out in the statutory statement-

(a) unless the paragraph in question specifies some other method of expression, the amounts shown shall be expressed in each case as a percentage of the weight of the feeding stuff as such; and

(b) phosphorus shall be expressed as "phosphorus P".

    (2) An expression of an amount as being within a range of percentages set out in the statutory statement shall not be regarded as compliance with sub-paragraph (1) above.

     25.  - (1) Subject to sub-paragraph (2) below, in the case of any compound pet food, or of any feeding stuff intended for a particular nutritional purpose for animals other than pet animals, particular attention may be drawn in the statutory statement, or elsewhere on the package, label or container, to the presence or low content of one or more feed materials which are essential aspects of the characteristics of the feeding stuff.

    (2) Where particular attention is drawn to the presence or low content of any feed material, as permitted by subparagraph (1) above, the minimum or maximum content, expressed in terms of the percentage by weight of that feed material, shall be clearly indicated-

(a) opposite the statement which draws attention to that presence or low content;

(b) in the list of feed materials; or

(c) by mentioning that presence or low content and the percentage thereof (by weight) opposite the corresponding category of feed materials.

     26.  - (1) Subject to subparagraph (2) below, in the case of any feeding stuff intended for a particular nutritional purpose, the following particulars shall be contained in the statutory statement-

(a) the term "dietetic";

(b) a description of the feeding stuff;

(c) the particular nutritional purpose of the feeding stuff, as specified in column 1 of Chapter A of Schedule 9;

(d) the essential nutritional characteristics of the feeding stuff, as specified in column 2 of that Chapter;

(e) the declarations prescribed in column 4 of that Chapter;

(f) the declarations, if any, prescribed in column 6 of that Chapter;

(g) where any declarations prescribed in that column do not include a declaration that it is recommended that the prior opinion of a veterinarian be sought, the words "It is recommended that a specialist's opinion be sought before use"; and

(h) the recommended length of time for use of the feeding stuff.

    (2) The particulars required by subparagraph (1) above to be contained in the statutory statement shall be declared in accordance with the requirements of paragraphs 3-7 and 9 of Chapter B of Schedule 9.

     27.  - (1) Subject to sub-paragraph (2) below, in the case of any feeding stuff intended for a particular nutritional purpose, particular attention may be drawn in the statutory statement, or elsewhere on the package, label or container, to the presence or low content of one or more analytical constituents which are essential aspects of the characteristics of the feeding stuff.

    (2) Where particular attention is drawn to the presence or low content of any analytical constituent, as permitted by sub-paragraph (1) above, the maximum or minimum content, expressed in terms of the percentage by weight of that analytical constituent, shall be clearly indicated in the list of analytical constituents.

     28.  - (1) In the case of any compound feeding stuff containing protein derived from mammalian tissue but containing no mammalian meat and bone meal, and intended for animals other than pet animals, the statutory statement shall contain the declaration specified in sub-paragraph (2) below.

    (2) The declaration referred to in subparagraph (1) above is-

" This compound feeding stuff contains protein derived from mammalian tissue the feeding of which to ruminants is prohibited".

     29. In the case of any compound feeding stuff containing mammalian meat and bone meal, and intended for animals other than pet animals, the statutory statement shall contain the following declaration-

" This compound feeding stuff contains protein derived from mammalian tissue the feeding of which to ruminants, all other categories of farmed creatures and equine animals is prohibited".

     30.  - (1) In the case of any product named as a permitted product in column 2 of Schedule 8, the statutory statement shall contain, in addition to any other particulars required by these Regulations, the name specified for that product in column 7 of that Schedule, together with such further particulars as may be specified in that column in relation to it.

    (2) In the case of any compound feeding stuff containing, for use as a protein source, any product named as a permitted product in column 2 of Schedule 8, the statutory statement shall contain, in addition to any other particulars required by these Regulations, the name specified for that product in column 7 of that Schedule, together with such further particulars as may be specified in that column in relation to compound feeding stuffs containing that product.

     31.  - (1) Subject to sub-paragraph (2) below, in the case of any compound feeding stuff, information may be provided in addition to the particulars required or permitted to be contained in the statutory statement or otherwise declared.

    (2) Any information provided pursuant to sub paragraph (1) above-

(a) shall be clearly separated from those particulars;

(b) shall not be designed to indicate the presence or content of analytical constituents other than those the declaration of which is provided for in this Schedule or in Schedule 9;

(c) shall relate to objective or quantifiable factors which can be substantiated;

(d) shall not be misleading, in particular by attributing to the feeding stuff effects or properties that it does not possess, or by suggesting that it possesses special characteristics, when all similar feeding stuffs contain similar properties;

(e) shall not claim that the feeding stuff will prevent, treat or cure a disease;

(f) shall not, in the case of any feeding stuff intended for a particular nutritional purpose, include a generic description other than in the form of the generic term "dietetic";

(g) shall not, in the case of any feeding stuff other than one intended for a particular nutritional purpose, include a generic description in that form; and

(h) shall not include reference to a particular pathological condition, unless-


(i) the feeding stuff is intended for a particular nutritional purpose; and

(ii) the particular nutritional purpose is specified in respect of that feeding stuff in column 1 of Chapter A of Schedule 9 and relates to that condition.

     32.  - (1) Subject to subparagraph (2) below, in the case of any feed material which is sold, or otherwise put into circulation, by any person, information may be provided in addition to the particulars required or permitted to be contained in the statutory statement or otherwise declared.

    (2) Any such information provided in addition to the particulars required or permitted to be contained in the statutory statement or otherwise declared-

(a) shall be clearly separated from those particulars;

(b) shall relate to objective or quantifiable factors which can be substantiated; and

(c) shall not be misleading.

(a) in the case of any additive permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of, the Table to Schedule 3 or which is otherwise authorised (not being an enzyme, micro-organism, zootechnical additive, an authorised intermediate product or an authorised medicated premix)-


(i) the name of the additive;

(ii) the EC registration number of the additive;

(iii) the name or business name and the address or registered business address of the person within the European Community responsible for the particulars referred to in this Part of this Schedule;

(iv) the net weight in the case of any non-liquid additive;

(v) either the net weight or the net volume in the case of any liquid additive; and

(vi) as from 1st April 2001, the approval or registration number allocated, pursuant to Article 5, or as the case may be, 10 of the Establishments Directive, to the establishment which manufactured the additive, or to the intermediary holding it;



(b) in the case of vitamin E-



(i) the alpha-tocopherol level as acetate; and

(ii) an indication of the period during which that level will remain present;



(c) in the case of any vitamin (other than vitamin E) or any added provitamin or substance having a similar effect-



(i) the active substance level; and

(ii) an indication of the period during which that level will remain present;



(d) in the case of any additive permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of, the Table to Schedule 3 or which is otherwise authorised (not being an enzyme, micro-organism, zootechnical additive, authorised immediate product or authorised medicated premix), the active substance level;

(e) in the case of any enzyme-



(i) the names of the active constituents according to their enzymatic activities as specified in the authorisation concerned;

(ii) the EC registration number;

(iii) the identification number allotted by the International Union of Biochemistry;

(iv) the name or business name and the address or registered business address of the person within the European Community responsible for the particulars referred to in this Part of this Schedule;

(v) the name or business name and the address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(vi) the activity units[101] per gram or per millilitre;

(vii) an indication of the period during which the activity units will remain present;

(viii) the batch reference number and the date of manufacture;

(ix) directions for use, including the recommended dosage or, where appropriate, range of dosages, expressed as a percentage by weight of target feed material per kilogram of feeding stuff, as prescribed in the authorisation concerned;

(x) any safety recommendation as specified in the authorisation concerned;

(xi) the net weight, in the case of any non-liquid enzyme;

(xii) either the net weight or the net volume, in the case of any liquid enzyme;

(xiii) an indication of any significant characteristics of the enzyme arising during manufacture, specified in the authorisation concerned; and

(xiv) as from 1st April 2001, the approval number allocated, pursuant to Article 5 of the Establishments Directive, to the establishment which manufactured the enzyme, or to the intermediary holding it; and



(f) in the case of any micro-organism-



(i) the identification of each strain, in accordance with the authorisation;

(ii) the file number of each strain;

(iii) the number of colony-forming units (expressed as CFU/g);

(iv) the EC registration number;

(v) the name or business name and the address or registered business address of the person within the European Community responsible for the particulars referred to in this Part of this Schedule;

(vi) the number or business name and the address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(vii) as from 1st April 2001, the approval number allocated, pursuant to Article 5 of the Establishments Directive, to the establishment which manufactured the micro-organism, or to the intermediary holding it;

(viii) an indication of the period during which the colony-forming units will remain present;

(ix) the batch reference number and the date of manufacture;

(x) directions for use;

(xi) any safety recommendation specified in the authorisation concerned;

(xii) the net weight, in the case of any non-liquid micro-organism;

(xiii) either the net weight or the net volume, in the case of any liquid micro-organism; and

(xiv) an indication of any significant characteristics of the micro-organism arising during manufacture, specified in the authorisation concerned.

     2. In addition to the information required under paragraph 1 above in relation to any additive, the statutory statement may also give-

(a) where the additive is permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of the Table to, Schedule 3, or otherwise authorised (and is not a zootechnical additive, an authorised intermediate product or an authorised medicated premix)-


(i) the trade name of the additive;

(ii) any other information, provided that it is clearly separated from the particulars referred to in paragraph 1(a) to (f) above and in subparagraph (i) above and (b) below; and



(b) where the additive falls within sub-paragraph (a) above and is not an enzyme or micro-organism-



(i) the name or business name, and the address or registered business address, of the manufacturer, if he is not the person responsible for the particulars referred to in this Part of this Schedule;

(ii) directions for use, including any appropriate safety recommendation.

(a) in the case of any premixture-


(i) the description "premixture";

(ii) directions for use, including any appropriate safety recommendation;

(iii) the species or category of animal for which the premixture is intended;

(iv) the name or business name, and the address or registered business address, of the person within the European Community responsible for the particulars referred to in this Part of this Schedule;

(v) the net weight of any non-liquid premixture;

(vi) either the net weight or the net volume of any liquid premixture; and

(vii) from 1st April 2001, the approval or registration number allocated, pursuant to Article 5, or as the case may be, 10 of the Establishments Directive, to the establishment which produced or manufactured the premixture, or to the intermediary holding it;



(b) in the case of any antioxidant, colourant (including pigment), trace element or preservative, in a premixture, for which a maximum content in a complete feeding stuff is prescribed in the appropriate Part of the Table to Schedule 3, or in another authorisation-



(i) the name of the additive; and

(ii) the active substance level;



(c) in the case of vitamin E in a premixture-



(i) the name of the additive;

(ii) the alpha-tocopherol level as acetate; and

(iii) an indication of the period during which that level will remain present;



(d) subject to paragraph (4) below, in the case of any vitamin other than vitamin E, or any provitamin or substance having a similar effect, in a premixture-



(i) the name of the additive;

(ii) the active substance level; and

(iii) an indication of the period during which that level will remain present;



(e) in the case of any enzyme in a premixture-



(i) the names of the active constituents according to their enzymatic activities, as specified in the authorisation concerned;

(ii) the EC registration number;

(iii) the identification number allotted by the International Union of Biochemistry;

(iv) the activity units (expressed as activity units per gram or activity units per millilitre);

(v) an indication of the period during which the activity units will remain present;

(vi) the batch reference number and the date of manufacture;

(vii) the name or business name and address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(viii) an indication of any significant characteristics of the enzyme arising during manufacture, as specified in the authorisation concerned; and

(ix) the recommended dosage or, where appropriate, range of dosages, expressed as a percentage by weight of target feed material per kilogram of the feeding stuff, as prescribed in the authorisation concerned;



(f) in the case of any micro-organism in a premixture-



(i) the identification of each strain, in accordance with the authorisation;

(ii) the file number of each strain;

(iii) the number of colony-forming units (expressed as CFU/g);

(iv) the EC registration number;

(v) the name or business name and the address or registered business address of the manufacturer, if he is not responsible for the particulars referred to in this Part of this Schedule;

(vi) an indication of the period during which the colony-forming units will remain present; and

(vii) an indication of any significant characteristics of the micro-organism arising during manufacture, specified in the authorisation concerned;



(g) in the case of any additive in a premixture-



(i) which is an additive of a type referred to in any of Parts I to VIII of Schedule 3, or which is otherwise authorised (other than any additive of a type referred to in sub-paragraphs (b) to (f) above), or which is an additive of a type referred to in any of those Parts, or in another authorisation, and in those sub-paragraphs, in respect of which no maximum level is laid down;

(ii) which fulfils a function in the feeding stuff as such; and

(iii) in respect of which the amount which is present in the premixture can be determined by using one of the methods of analysis specified in Annex I to Part II of Schedule 2 to the Feeding Stuffs (Sampling and Analysis) Regulations 1999[102] or by some other valid scientific method, the name of the additive and the active substance level.

     3. In relation to an additive permitted to be contained in material pursuant to paragraph 5(1) of, or referred to in any of Parts I to VIII of the Table to, Schedule 3, or which is otherwise authorised, in a premixture, in addition to the information required under paragraph 2 above, the statutory statement may give-

(a) the trade name of the additive;

(b) in the case of any additive not being an enzyme or a micro organism, its EC registration number;

(c) any other information, provided that it is clearly separated from the particulars referred to in paragraph 2 above, and in the foregoing provisions of this paragraph.

     4. In the case of a premixture containing more than one vitamin (other than vitamin E), provitamin or substance having a similar effect, the requirement in paragraph 2(d)(iii) above shall apply only to whichever of those additives has the shortest such period.