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Supply of part of sample to manufacturer
78.
If the person who manufactured any material of which an authorised person has taken a sample is not a person to whom part of the sample is required to be sent under regulation 77, that regulation shall have effect as if, for the reference to three parts, there were substituted a reference to four parts, and the authorised person shall send the fourth part to the manufacturer, unless he does not know the manufacturer's name, or any address of his in the United Kingdom, and is unable, after making reasonable enquiries, to ascertain the name or, as the case may be, any such address, before the expiration of fourteen days from the date when the sample was taken.
Statement to accompany sample
79.
There shall be sent, with the part of the sample sent pursuant to regulation 77, a statement signed by the authorised person that the sample was taken in the manner referred to in regulation 76(8).
Analysis by analyst
80.
The analyst shall analyse the part of the sample sent to him under regulation 77, and send a certificate of the analysis, completed in the form set out in Schedule 4, and in accordance with the notes set out in that Schedule, to the authorised person, who shall send a copy to-
(a) the person who was subjected to the official check concerned, and
(b) any person to whom he has sent a part of the sample pursuant to regulation 78.
Alternative arrangements for carrying out analyses
81.
If the analyst to whom a sample is sent for analysis under regulation 77 determines that an effective analysis of the sample cannot be made by him or under his direction, he shall send it to another analyst or, in Northern Ireland, to another agricultural analyst in Northern Ireland, together with any documents received by him with the sample, and thereupon regulation 80 shall apply, as if the sample had originally been sent to that other analyst or, as the case may be, agricultural analyst in Northern Ireland.
Further analysis of samples
82.
- (1) Where a part of a sample sent pursuant to regulation 77 has been analysed, and it is intended to institute proceedings, or proceedings have been commenced, against a person for an offence under regulation 85(a), (b) or (c), and it is intended to adduce, on behalf of the prosecution, evidence of the result of the analysis of that part of the sample, the defendant, for the purpose of obtaining a second opinion, may request the authorised person to send the retained part of the sample for analysis to-
(a) where the sample was taken in Great Britain, the Government Chemist, and
(b) where the sample was taken in Northern Ireland, the Chief Agricultural Analyst.
(2) Where a defendant requests the authorised person to send the retained part of the sample to the Government Chemist or, as the case may be, the Chief Agricultural Analyst, pursuant to paragraph (1), the following procedure shall (subject to paragraph (3)), be followed-
(a) the authorised person shall-
(i) send the retained part of the sample for analysis to the Government Chemist or, as the case may be, the Chief Agricultural Analyst, and
(ii) supply the defendant with a copy of the Government Chemist's or, as the case may be, the Chief Agricultural Analyst's, certificate of analysis of that part of the sample; and
(b) the Government Chemist or, as the case may be, the Chief Agricultural Analyst, shall analyse the part of the sample sent to him under sub-paragraph (a) above and shall send to the authorised person a certificate of the analysis, completed in the form set out in Schedule 4, and in accordance with the notes set out in that Schedule.
(3) The authorised person may in any case give notice in writing to the defendant requesting payment of a fee specified in the notice in respect of performance of the functions specified in paragraph (2)(b) and, if the fee so specified exceeds neither-
(a) the cost of performing them, nor
(b) the appropriate fee for the performance of any similar function under section 78 of the 1970 Act,
the authorised person may, in the absence of agreement by the defendant to pay the fee, refuse to comply with the request made under paragraph (1).
(4) In this regulation "defendant" includes a prospective defendant.
Default Powers of the Minister of Agriculture, Fisheries and Food
83.
For the purposes of this Part of these Regulations, if the Minister is of opinion that, in any area within Great Britain, these Regulations have been-
(a) insufficiently enforced or administered, or
(b) if applicable, enforced without sufficient regard to the requirements of Directive 95/53/EC,
he may himself appoint one or more persons to exercise in that area the powers exercisable there by authorised persons; and any expenses certified by him as having been incurred by him under this regulation shall be repaid to him, on demand, by the enforcement authority.
Methods of Analysis
84.
- (1) Subject to paragraphs (2) and (3), for the purpose of determining, by means of analysis of a part of a sample taken in the course of the carrying out of official checks, whether a substance-
(a) of a class or description listed in column 1 of Part I of Schedule 5, or
(b) to which the method of analysis set out in Part II, or the method set out in Part III, of that Schedule, relates,
is present in that part, or what quantity or proportion of such a substance is present therein,
(i) the provisions specified, in the case of Great Britain, in Part I of Schedule 2 to the Feeding Stuffs (Sampling and Analysis) Regulations 1999 or, in the case of Northern Ireland, in Part I of Schedule 2 to the Feeding Stuffs (Sampling and Analysis) (Northern Ireland) Regulations 1999, under the heading "GENERAL PROVISIONS", shall have effect, in the like manner as they have effect under the Regulations in question in relation to feeding stuffs;
(ii) in relation to a substance of a class or description listed in column 1 of Part I of Schedule 5, the relevant method of analysis set out in the European Community provision in force specified in the corresponding entry in column 2 of that Part shall be used; and
(iii) in relation to a substance to which the method of analysis set out in Part II, or the method set out in Part III, of that Schedule relates, the method applicable to that substance shall be used.
(2) Paragraph (1) shall not apply before 1st November 1999 in the case of the following substances listed in column 1 of Part I of Schedule 5-
(a) carbadox; and
(b) diclazuril.
(3) After 31st October 1999, paragraph (1) shall-
(a) cease to apply to the following substances listed in column 1 of Part I of Schedule 5-
(i) ethopabate,
(ii) dinitolmide,
(iii) menadione (vitamin K3),
(iv) nicarbazin, and
(v) vitamin A;
(b) have effect, in the case of the substance amprolium, which is included in the list in column 1 of Part I of Schedule 5, with the substitution, for the words appearing in column 2 of that Part opposite to the entry for that substance, of the words "Part A of the Annex to Directive 1999/27/EC."[25].
(4) For the purpose of determining, by means of analysis as aforesaid, whether a substance other than one to which paragraph (1) applies is present in the part of a sample concerned, or what quantity or proportion of such a substance is present therein-
(a) if there is an applicable standard of the kind referred to in the first indent of Article 18.3 of Directive 95/53/EC, analysis shall be carried out in accordance with that standard, and
(b) if there is no such standard, it shall be carried out in accordance with any scientifically valid method the application of which does not contravene any general principle of the Treaty establishing the European Community.
Offences
85.
It shall be an offence for a person-
(a) without reasonable excuse, to contravene any provision of regulation 33, 35, 36, 37, 39, 41(1) or (2), 42(1), 43(1), (2) or (54), 44(1) or (2), 45, 49, 51, 52, 53, 55, 57(1), 58(1), 59(1), 60, 61, 63, 65, 66(1), 67, 68(1), 69 to 72 inclusive, 73(1) or 74;
(b) without reasonable excuse, to fail to comply with any provision of regulation 34, 38, 40, 46, 47(1), 48, 50, 54, 56, 62 or 64;
(c) in connection with these Regulations to make a statement which he knows to be false in a material particular, or recklessly to make a statement which is false in a material particular;
(d) intentionally to obstruct an authorised person in the exercise of a power conferred by regulation 76; or
(e) without reasonable excuse, to fail to comply with any requirement lawfully made of him, pursuant to regulation 76, by an authorised person.
Punishment of offences
86.
- (1) Any person who commits any of the offences set out in regulation 85(a) or (c) shall be liable-
(a) on summary conviction, to a fine not exceeding the statutory maximum; and
(b) on conviction on indictment, to a fine.
(2) Any person who commits any of the offences set out in regulation 85(b) shall be liable on summary conviction to a fine not exceeding level 5 on the standard scale.
(3) Any person who commits any of the offences set out in regulation 85(d) or 85(e) shall be liable on summary conviction to a fine not exceeding level 3 on the standard scale.
Time limit for prosecutions
87.
- (1) Proceedings for an offence under regulation 85(b) or (c) may, subject to paragraph (2) below, be commenced within the period of six months from the date on which evidence sufficient in the opinion of the prosecutor to warrant proceedings comes to his knowledge.
(2) No such proceedings shall be commenced by virtue of this regulation more than two years after the commission of the offence.
(3) For the purpose of this regulation, a certificate signed by or on behalf of the prosecutor and stating the date on which evidence sufficient in his opinion to warrant the proceedings came to his knowledge shall be conclusive evidence of that fact.
(4) A certificate stating that matter and purporting to be so signed shall be deemed to be so signed unless the contrary is proved.
(5) In relation to proceedings in Scotland, subsection (3) of section 136 of the Criminal Procedure (Scotland) Act 1995[26] (date of commencement of proceedings) shall apply for the purposes of this regulation as it applies for the purposes of that section.
Offences by bodies corporate and Scottish partnerships
88.
- (1) Where a body corporate is guilty of an offence under these Regulations, and that offence is proved to have been committed with the consent or connivance of, or to be attributable to, any neglect on the part of-
(a) any director, manager, secretary or other similar officer of the body corporate, or
(b) any person who was purporting to act in any such capacity,
he, as well as the body corporate, shall be guilty of the offence and be liable to be proceeded against and punished accordingly.
(2) For the purposes of paragraph (1), "director" in relation to a body corporate whose affairs are managed by its members, means a member of the body corporate.
(3) Where a Scottish partnership is guilty of an offence under these Regulations in respect of an act or default which is shown to have been committed with the consent or connivance of, or to be attributable to any neglect on the part of, a partner in the partnership, he, as well as the partnership, shall be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Defence
89.
Where a person responsible for putting a zootechnical product into circulation is charged with an offence under these Regulations in respect of a product that has been manufactured or assembled to his order by another person and which has been so manufactured or assembled so as not to comply with his order, it shall be a defence for him to prove-
(a) that, in placing his order, a copy of the documents relating to the manufacture and assembly of the product were available, or had been provided, to that other person and the person responsible for putting the product into circulation had instructed that other person to manufacture or assemble the product in accordance with those documents,
(b) that if that other person had complied with that instruction, no offence would have been committed, and
(c) that the person responsible for putting the product into circulation did not know, and could not by the exercise of reasonable care have known, that those instructions had not been complied with.
Supplementary provisions relating to sampling and analysis, prosecutions, offences and defences
90.
- (1) Any analysis required to be made by an analyst or, as the case may be, the Government Chemist or the Chief Agricultural Analyst, may be made by any person acting under his directions.
(2) A certificate of analysis completed in accordance with these Regulations shall, in any legal proceedings, be received as evidence of the facts stated therein, if the party against whom it is to be given in evidence has been served with a copy of it not less than twenty-one days before the hearing, and has not, before the seventh day preceding the hearing, served on the other party a notice requiring the attendance of the person who made the analysis.
(3) In any legal proceedings in Scotland, a certificate of analysis received in evidence by virtue of paragraph (2) or, where the attendance of the person who made the analysis is required under that paragraph, the evidence of that person, shall be sufficient evidence of the facts stated in the certificate.
(4) Any document purporting to be a certificate of the kind referred to in paragraphs (2) and (3) shall be deemed to be such a certificate unless the contrary is proved.
(5) Subject to paragraph (6), for the purposes of this Part of these Regulations, sections 80(1), 81 and 82 and 110 of the 1970 Act shall have effect, as if these Regulations were made under section 74A(4) of that Act.
(6) For the purposes of paragraph (5)-
(a) section 82(1) of the 1970 Act shall have effect as if, for the words "any of the following provisions of this Act, namely, sections 68 (1A), (4)(b) and (c), 69(4)(c), 70(2), 71(2)(b), 73, 73A and 74A" there were substituted the words "the Feedingstuffs (Zootechnical Products) Regulations 1999", and
(b) section 110(1) of the 1970 Act shall have effect as if, for the words "this Act or any order or scheme made thereunder" there were substituted the words "the Feedingstuffs (Zootechnical Products) Regulations 1999".
Service of notices
91.
Any certificate, notice or part of a sample, required to be served on a person under any provision of these Regulations may be served-
(a) by delivering it to him;
(b) by leaving it at the usual or last known place of abode or business of that person, or, in a case where an address for service has been given by that person, at that address;
(c) by sending it in a prepaid registered letter, or by the recorded delivery service, addressed to that person at his usual or last-known place of abode or business or, in a case where an address for service has been given by that person, at that address; or
(d) in the case of a body corporate, by delivering it to the secretary or clerk of the body corporate at its registered or principal office or by sending it in a prepaid registered letter, or by the recorded delivery service, addressed to the secretary or clerk of that body corporate at that office.
Exclusion of application of the Medicines Act 1968
92.
- (1) Except as specified in paragraphs (2) and (3), the 1968 Act, and instruments made wholly or partly under that Act, shall continue not to apply to zootechnical products.
(2) The function bestowed on any committee, established under section 4 (establishment of committees) of the 1968 Act, of giving advice on veterinary medicinal products, shall include the giving of advice on zootechnical products.
(3) The provisions of sections 32 to 36 (other than section 35(8)(a)), 38 and 39 of the 1968 Act, and instruments made under any of those provisions, shall continue to apply to unauthorised zootechnical additives as if paragraph (1) had not come into force.
Amendment of the Feeding Stuffs (Sampling and Analysis) Regulations 1999
93.
For regulation 3 of the Feeding Stuffs (Sampling and Analysis) Regulations 1999[27](manner of taking, preparing, marking, sealing and fastening of samples) there shall be substituted the following regulation:
"
Manner of taking, preparing, marking, sealing and fastening of samples
3.
The manner in which samples of feeding stuffs are to be taken, prepared, marked, sealed and fastened shall be as prescribed in Schedule 1, and paragraph 10 of Part II of that Schedule shall have effect for the purposes of the certificate referred to in regulation 7.".
Jeff Rooker
Minister of State, Ministry of Agriculture, Fisheries and Food
29th June 1999
Calum MacDonald
Parliamentary Under Secretary of State, Scottish Office
29th June 1999
SCHEDULE 1Regulation 2(1)
EC REGULATIONS DELETING ADDITIVES FROM ANNEX B OF DIRECTIVE 70/524/EEC
1.
Commission Regulation (EC) No. 2788/98 (OJ No. L347, 23.12.98, p. 31) amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards the withdrawal of authorisation for certain growth promoters.
2.
Council Regulation (EC) No. 2821/98 (OJ No. L351, 29.12.98, p. 4) amending, as regards withdrawal of the authorisation of certain antibiotics, Directive 70/524/EEC concerning additives in feedingstuffs.
3.
Commission Regulation (EC) No. 45/1999 (OJ No. L6, 12.1.1999, p. 3) amending Council Directive 70/524/EEC concerning additives in feedingstuffs as regards withdrawal of the authorisation of certain additives belonging to the group of coccidiostats and other medicinal substances.
SCHEDULE 2Regulation 2(2), (3) and (4)
SUPPLEMENTARY PROVISIONS RELATING TO INTERPRETATION
PART I
Expressions having the same meaning as in Directive 70/524/EEC
coccidiostats and other medicinal substances
compositional characteristics
PART II
>Expressions having the same meaning as in Directive 70/524/EEC as amended by Directive 96/51/EC
last stage of circulation
representative within the Community
toxicological tests on vertebrates
unforeseen undesirable interaction
PART III
Expressions having the same meaning as in Directive 95/69/EC
SCHEDULE 3Regulations 6(8)(b), 9(1), 15(1) and 23(1)
FEES
PART I
Fees payable in relation to the submission of dossiers
|
Application
|
Fee (£) per dossier
|
| Application under regulation 5(3)
|
25,000
|
| Application under regulation 6(1)
|
25,000
|
| Application under regulation 7(1)(a)
|
25,000
|
| Appication under regulation 7(1)(b)
|
10,000
|
| Application under regulation 8(1)
|
2,500
|
PART II
Fees payable in relation to the approval of establishments
|
Application
|
Fee (£)
|
|
Application under regulation 10(1)(a) or 12 for approval of an establishment to manufacture a zootechnical additive |
405 |
|
Application under regulation 10(1)(b) or 12 for approval of an establishment to manufacture a zootechnical premixture |
405 |
|
Application under regulation 10(1)(c) or 12 for approval of an establishment to manufacture a zootechnical compound feedingstuff |
113 |
|
Application under regulation 10(1)(d) or 12 for approval of an establishment to produce a zootechnical compound feedingstuff for the exclusive requirements of the applicant's holding |
113 |
|
Application under regulation 10(1)(e) or 12 for approval of an establishment to manufacture a zootechnical compound feedingstuff using a minimum proportion of 0.05% by weight of a premixture |
405 |
PART III
Fees payable in relation to the approval of intermediaries
|
Application
|
Fee (£)
|
|
Application for approval under regulation 18 or 20 to exercise an intermediary activity
|
151
|
SCHEDULE 4
Reguation 80 and 82(2)(b)
FORM OF CERTIFICATE OF ANALYSIS
CERTIFICATE OF ANALYSIS OF SAMPLE OF PRODUCT ANALYSED PURSUANT TO THE FEEDINGSTUFFS (ZOOTECHNICAL PROCUCTS) REGUJLATIONS 1999(1)
I, the undersigned, analyst at the (2) laboratory/agricultural analyst for the (3) /agricultural analyst in Northern Ireland/Government Chemist/Chief Agricultural Analyst, in pursuance of the provisions of then Feedingstuffs (Zootechnical Products) Regulations 1999, hereby certify that I received on the day of 19 , from (4) one part of a sample of (5) for analysis; which was duly sealed and fastened up and marked (6) and was accompanied by a (7) and also by a signed statement that the sample was taken in the manner referred to in regulation 76(8) of th0se Regulations; that (8) and that the said part has been analysed by me, or under my direction, and I declare the results of analysis to be as follows: - (9)
(A) specific method(s) is/are prescrived in the Feedingstuffs (Zootechnical Products) Regulations 1999 for the analysis of (10) and that/those method(s) was/were used in the analysis and/or
No specific method(s) is/are prescrived in the Feedingstuffs (Zootechnical Products) regjulations 1999 for the analysis of (10) and the method(s) used complied with regulation 84(4) of those regulations (11)
Name of analyst/agricultural analyst/Government Chemist/Chief Agricultural Analyst (print)
Signature of analyst/agricultural analyst/Government chemist/Chief Agricultural Analyst/person authorised by person named above to sign this certificate
Address
Date
NOTES
(1) Statements made in certificates are to be confined to matters which are necessary to verify compliance with the Feedingstuffs (Zootechnical Products) Regulations 1999.
(2) Insert name of laboratory.
(3) Insert name of the local authority.
(4)Insert the name of the authorised person who submitted the sample of analysis; and also the mode of transit, for example "by hand", "by registered post", "by rail", as the case may be.
(5) Insert the name or description applied to the material.
(6) Insert the distinguisinng mark on the sample and the date of sampling shown thereon.
(7) Insert description of any document accompanying the sample.
(8) Insert details of particulars contained in any accompanying document, or particulars marked on, or indicated by a mark applied to, the material, or as the case may be.
(9)Insert relevant results, including -
(a) identification of the type of product concerned (e.g. compound feeding stuff, complete feeding stuff, additive etc.);
(b) the name or names of any additive or premixture comprising or contained in the product;
(c) the amount of any additive comprising or contained in the product, having regard to any maximum or minimum level specified in respect of the additive for the purposes of Directive 70/524/EEC as amended by Directive 96/51/EEC, and referred to a complete feeding stuff with a moisture contend of 12%.
(10) List substance(s).
(11) Delete as applicable and indicate the method of analysis used. If analysis cannot be carried out because no suitable method exists then the certificate should be noted accordingly.
Notes:
[25]
OJ No. L118, 6.5.99, p. 36.back
[26]
1995 c.46.back
[27]
S.I. 1999/1663.back
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