AGRICULTURE Title and commencement 1 These Regulations may be cited as the Feeding Stuffs (Amendment) (No. 2) Regulations 1994 and shall come into force on the following dates: a regulations 1—3, 4(1)(b), (2), (3) and the Schedules on 1st October 1994; b the remainder on 1st January 1995. Amendment of the Feeding Stuffs Regulations 1991 2 The Feeding Stuffs Regulations 1991 shall be further amended in accordance with regulations 3 and 4 below. 3 In regulation 13— a for paragraph (1) there shall be substituted the following paragraph: 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 containing any additive, or sell, or have in possession with a view to sale for incorporation in a feeding stuff, any additive unless— a where the additive is contained in any material, the material complies with the relevant provisions of Schedule 4; b where the additive is not so contained, it is referred to in the Table to Schedule 4; or c the additive, whether or not contained in any material or in a preparation is— i an enzyme (other than of a type referred to in Part X of that Table); or ii a micro-organism. ; b after paragraph (1) there shall be inserted the following paragraphs: 1A No person shall— a sell, or have in possession with a view to sale for use as a feeding stuff, or use as a feeding stuff, any material containing any additive which is an enzyme (other than of a type referred to in Part X of the Table to Schedule 4) or a micro-organism, whether or not the enzyme or micro-organism is contained in a preparation, or b sell, or have in possession with a view to sale, for incorporation in a feeding stuff, any such enzyme or micro-organism, unless, in accordance with Article 3(a) of Council Directive 93/113/ EC , and before 15th October 1994— i an identification note in the form contained in Annex II to that Directive, relating to the enzyme, micro-organism or preparation in question, and prepared by the person responsible for selling or otherwise supplying the same, has been received by the Minister of Agriculture, Fisheries and Food; and ii the enzyme or, as the case may be, micro-organism or preparation, is included in the list of authorised products referred to in that Article. 1B No person shall, on or after 1st December 1995— a sell, or have in possession with a view to sale for use as a feeding stuff, or use as a feeding stuff, any material containing any additive which is an enzyme (other than of a type referred to in Part X of the Table to Schedule 4) or a micro-organism, whether or not the enzyme or micro-organism is contained in a preparation, or b sell, or have in possession with a view to sale for incorporation in a feeding stuff, any such enzyme or micro-organism, unless, in accordance with Article 3(b) of Council Directive 93/113/EC , and before that date, a dossier relating to the enzyme, micro-organism or preparation in question, and prepared by the person who requested its inclusion in the list of authorised products referred to in paragraph (1A)(b)(ii) above, has been received by the Minister of Agriculture, Fisheries and Food. ; c in paragraph (2), for the words “Paragraph (1)” their shall be substituted the words “Paragraphs (1)—(1B)”. 4 1 In Part I of Schedule 1 (“CONTENTS OF THE STATUTORY STATEMENT”)— a in paragraph 2— i after sub-paragraph (1)(d) there shall be inserted the following provisions: e enzymes of a type referred to in Part X of the Table to Schedule 4— i the names of the active constituents according to their enzymatic activities specified in column 3 of that Part; ii the identification number allotted by the International Union of Biochemistry; iii the activity units (expressed as activity units per kilogram or activity units per litre); iv an indication of the period during which the activity units will remain present; and v an indication of any significant characteristics of the enzyme arising during manufacture, specified in column 8 of that Part; f enzymes not of a type referred to in Part X of the Table to Schedule 4, where the material is a compound feeding stuff— i the names of the active constituents according to their enzymatic activities; ii the identification number allotted by the International Union of Biochemistry; iii the activity units (expressed as activity units per kilogram or activity units per litre) if such units can be measured by an official or scientifically valid method; and iv an indication of the period during which the activity units will remain present; g micro-organisms, where the material is a compound feeding stuff— i the identification of the strain(s) according to a recognised international code of nomenclature; ii the deposit number of the strain(s); iii the number of colony-forming units (expressed as CFU/ kg ) if the number is measurable by an official or scientifically valid method; iv an indication of the period during which the colony-forming units will remain present; and v an indication of any significant characteristics of the micro-organism arising during manufacture. ; ii for sub-paragraph (2)(c) there shall be substituted the following sub- paragraph: c any other added substance (other than an enzyme of a type not referred to in Part X of the Table to Schedule 4 or a micro-organism) its EEC number or its trade name. ; iii in sub-paragraph (5), after the word “accompanied” there shall be added the words “(other than in the case of an enzyme of a type not referred to in Part X of the Table to Schedule 4 or a micro-organism)”; b in paragraph 7— i after sub-paragraph (1)(b) there shall be added the following sub-paragraph: c If the feeding stuff is constituted from no more than three ingredients, and clearly described by reference to its ingredients either in the statutory statement or elsewhere on its package, label or container, the declarations specified in (b) above shall not be required. ; ii sub-paragraph (2)(c) shall be deleted. 2 In Schedule 4 (“PERMITTED ADDITIVES AND PROVISIONS RELATING TO THEIR USE”)— a after paragraph 11 there shall be added the following provisions: 12 No material shall contain— a any added enzyme, other than one named or described in column 2 of Part X; or b any added enzyme named or described in column 2 of that Part unless— i the material is for a species or category of animal listed opposite the enzyme in question in column 4 of that Part and the animal concerned is of an age no greater than that (if any) specified in column 5 of that Part; ii taking into account any such enzyme which is naturally present, the content of the enzyme is not less than the minimum (if any) specified in column 6 of that Part, and does not exceed the maximum (if any) specified in column 7 of that Part; and iii the material is to be used in accordance with the conditions (if any) laid down in column 8 of that Part. ; b for Part II (“PERMITTED COLOURANTS”), there shall be substituted the contents of Schedule 1 to these Regulations; c in Chapter B of Part III (“PERMITTED EMULSIFIERS, STABILISERS, THICKENERS AND GELLING AGENTS”), there shall be inserted at the beginning, in columns 1—3 and 5, the following provisions: E418 Gellan gum (Polytetrasaccharide containing glucose, glucuronic acid and rhamnose (2:1:1) produced by Pseudomonas elodea (ATCC31466)) Dogs, Cats — Canned feeding stuffs only d in Chapter B of Part IV (“PERMITTED BINDERS, ANTI-CAKING AGENTS AND COAGULANTS”), there shall be added at the end the following provisions: 2 Natrolit e— phonolite (Natural mixture of aluminium silicates, alkalines and alkaline — earth and aluminium hydrosilicates, natrolite (43%—46%) and feldspar) All species of animals 25000 All feeding stuffs e in Part IX (“PERMITTED ACIDITY REGULATORS FOR PET FOODS FOR DOGS AND CATS”), after the provisions relating to Sodium hydroxide there shall be added the following provisions: E525 Potassium hydroxide E526 Calcium hydroxide f after Part IX there shall be added the contents of Schedule 2 to these Regulations. 3 In Chapter A of Part I of Schedule 5 (“FEEDING STUFFS”), for the provisions relating to complete feeding stuffs in columns 2 and 3, opposite the reference in column 1 to the substance Arsenic, there shall be substituted the following provisions: Complete feeding stuffs except: 2 — complete feeding stuffs for fish 4 4 In Part I of Schedule 8 (“ADDITIVES”)— a for paragraph 1(a) there shall be substituted the following sub-paragraph: a in the case of any additive referred to in the Table to Schedule 4 (other than an enzyme): i the name of the additive; ii the name or business name and the address or registered business address of the person responsible within the European Economic Community for the particulars referred to in this Part of this Schedule; iii the net weight of any non-liquid additive; and iv either the net weight or the net volume of any liquid additive. ; b for paragraph 1(d) there shall be substituted the following sub-paragraph: d in the case of any trace element, colourant (including pigment), preservative or other additive referred to in the Table to Schedule 4 not specified above (other than an enzyme), the active substance level. ; c after paragraph 1(d) there shall be added the following sub-paragraphs: e in the case of any enzyme (whether or not contained in a preparation where the enzyme is not of a type referred to in Part X of the Table to Schedule 4): i the names of the active constituents according to their enzymatic activities (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part); ii the identification number allotted by the International Union of Biochemistry; iii the name or business name and the address or registered place of business of the person responsible for the particulars referred to in this sub-paragraph; iv the name or business name and the address or registered place of business of the manufacturer if he is not responsible for the particulars in the label or mark; v the activity units (expressed as activity units per gram or activity units per millilitre); vi an indication of the period during which the activity units will remain present; vii the batch reference number and the date of manufacture; viii directions for use, including any safety recommendation (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part); ix the net weight of any non-liquid additive; x either the net weight or the net volume of any liquid additive; and xi in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, an indication of any significant characteristics of the enzyme arising during manufacture specified in column 8 of that Part; f in the case of any micro-organism (whether or not contained in apreparation): i the identification of the strain(s) according to a recognised international code of nomenclature; ii the deposit number of the strain(s); iii the number of colony-forming units (expressed as CFU/g); iv the name or business name and address or registered place of business of the person responsible for the particulars referred to in this sub-paragraph; v the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars in the label or mark; vi an indication of the period during which the colony-forming units will remain present; vii the batch reference number and the date of manufacture; viii directions for use, including any safety recommendation; ix the net weight of any non-liquid additive; x either the net weight or the net volume of any liquid additive; and xi an indication of any significant characteristics of the micro-organism arising during manufacture. ; d after paragraph 2(c) there shall be added the following sub-paragraph: d any other information, provided that it is clearly separated from the particulars referred to in paragraph 1(a)-(d) above and in the foregoing provisions of this paragraph, and from the relevant particulars referred to in paragraph 1(e) above. ; e after paragraph 2 there shall be added the following paragraph: 3 In the case of any enzymes (other than of a type referred to in Part X of the Table to Schedule 4) or micro-organism, whether or not the enzyme or micro-organism is contained in a preparation, the label or mark may give any other information, provided that it is clearly separated from the relevant particulars referred to in paragraph 1(e) and (f) above. . 5 In Part II of Schedule 8 (“PREMIXTURES”)— a in paragraph 1(a), there shall be added at the end the following provisions: v the net weight of any non-liquid premixture; and vi either the net weight or the net volume of any liquid premixture; ; b after paragraph 1(d) there shall be inserted the following sub-paragraphs: e in the case of any enzyme in a premixture: i the names of the active constituents according to their enzymatic activities (in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, as specified in column 3 of that Part); ii the identification number allotted by the International Union of Biochemistry; iii the activity units (expressed as activity units per gram or activity units per millilitre); iv an indication of the period during which the activity units will remain present; v the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars referred to in the label or mark; and vi in the case of an enzyme of a type referred to in Part X of the Table to Schedule 4, an indication of any significant characteristics of the enzyme arising during manufacture, specified in column 8 of that Part; f in the case of any micro-organism in a premixture: i the identification of the strain(s) according to a recognised international code of nomenclature; ii the deposit number of the strain(s); iii the number of colony-forming units (expressed as CFU/g); iv an indication of the period during which the colony-forming units will remain present; v the name or business name and address or registered place of business of the manufacturer if he is not responsible for the particulars referred to in the label or mark; and vi an indication of any significant characteristics of the microorganism arising during manufacture; ; c for paragraph 1(e) there shall be substituted the following sub-paragraph: g in the case of any additive in a premixture— i which is an additive of a type referred to in the Table to Schedule 4 (other than any additive of a type referred to in sub-paragraphs (b)-(e) above) or an additive of a type referred to in that Table and in those subparagraphs 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 Schedule 2 to the Feeding Stuffs (Sampling and Analysis) Regulations 1982 , or by some other valid scientific method— A the name of the additive, and B the active substance level. . d for paragraph 2 there shall be substituted the following paragraph: 2 In relation to any additive referred to in the Table to Schedule 4, the label or mark may give— a the trade name of the additive; or b its EEC number; or c both such trade name and the EEC number; and d any other information, provided that it is clearly separated from the particulars referred to in paragraph 1(a)-(d) above and in the foregoing provisions of this paragraph, and from the relevant particulars referred to in paragraph 1(e) above ; e after paragraph 2 there shall be added the following paragraph: 2A In relation to any enzyme (other than of a type referred to in Part X of the Table to Schedule 4) or micro-organism, in a premixture, the label or mark may give any other information provided that it is clearly separated from the relevant particulars referred to in paragraphs 1(a), (e) and (f) above. . In witness whereof the Official Seal of the Minister of Agriculture, Fisheries and Food is hereunto affixed on William Waldegrave Minister of Agriculture, Fisheries and Food 5th September 1994. James Douglas-Hamilton Parliamentary Under Secretary of State, Scottish Office 1st September 1994 Signed by authority of the Secretary of State for Wales Gwilym Jones Parliamentary Under Secretary of State, Welsh Office 31st August 1994