1 Title and commencement

These Regulations may be cited as the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) (Amendment) Regulations 2013 and come into force on 6th May 2013.

NOTES
Initial Commencement
Specified date

Specified date: 6 May 2013: see above.

2 Amendment of the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997

2Amendment of the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997

(1)    The Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 are amended in accordance with this regulation.

(2)    In regulation 2(1)—

(a)    omit the definition of “Annex IV substance”;

(b)    for the definition of “Council Directive 96/22” substitute—

““Council Directive 96/22” means Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of beta-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/ECC;”;

(c)    for the definition of “Council Directive 96/23” substitute—

““Council Directive 96/23” means Council Directive 96/23/EC on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC;”;

(d)    omit the definition of “the Council Regulation”;

(e)    in the definition of “maximum residue limit” for “Annex I or Annex III to the Council Regulation in the tissues or body fluids of an animal or in an animal product, the limit specified in the fourth column” substitute “Table 1 in the tissues or body fluids of an animal or in an animal product, the limit (if any) specified in the fourth column”;

(f)    after the definition of “reference analysis certificate” insert—

““Regulation 470/2009” means Regulation (EC) No 470/2009 of the European Parliament and of the Council laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council;

“Regulation 37/2010” means Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin;”;

(g)    after the definition of “sale” insert—

““Table 1” means Table 1 of the Annex to Regulation 37/2010, and “Table 1 substance” means a substance specified in the first column of Table 1;

“Table 2 substance” means a substance specified in Table 2 of the Annex to Regulation 37/2010;”;

(h)    in the definition of “unauthorised substance” for “an Annex IV substance” substitute “a Table 2 substance”; and

(i)    in the definition of “unlicensed substance” for “Annex IV substance” substitute “Table 2 substance”.

(3)    For regulation 2(2) substitute—

“(2)    For the purpose of ascertaining whether the maximum residue limit has been exceeded for the purposes of these Regulations—

(a)    the presence of the drug or drug metabolite (or combination thereof) specified in the second column (marker residue) of Table 1 opposite the corresponding entry in the first column (pharmacologically active substance) of that Table shall be taken to indicate the presence of that substance in that part of an animal or batch of animals, or in any animal product derived from that part of an animal or batch of animals, specified in the corresponding entry in the fifth column (target tissues) of that Table; and

(b)    the maximum residue limit (if any) specified in the fourth column of that Table in the entry corresponding to that substance shall apply in respect of the presence in such part of an animal or batch of animals, or in any animal product derived from such part of an animal or batch of animals, of any such drug or drug metabolite (or combination thereof) as if it were that substance.”.

(4)    In regulation 2(3) for “the Council Regulation” substitute “Regulation 470/2009”.

(5)    Omit regulation 2(3A).

(6)    After regulation 2(3A) insert—

“(3B)    Any reference in these Regulations to an Annex to Council Directive 96/22, Council Directive 96/23 or Regulation 37/2010 is a reference to that Annex as amended from time to time.”.

(7)    For regulation 7 substitute—

“7 Prohibition of administration of Table 2 substances

It is an offence to contravene Article 14(6) of Regulation 470/2009 (prohibition on administration of substances to food-producing animals in certain circumstances).”.

(8)    For regulation 9(1)(e), substitute—

“(e)    which contains a Table 1 substance at a concentration exceeding the maximum residue limit; or”.

(9)    In regulation 15(1), for the words “the analyst shall” to “the relevant person” substitute “the analyst shall record that information in a primary analysis certificate and provide a copy of that certificate to an authorised officer who shall then give that copy to the relevant person”.

(10)    For regulation 16(2) substitute—

“(2)    The analyst shall record the results of the reference analysis in a reference analysis certificate and provide a copy of that certificate to an authorised officer who shall then give this copy to the relevant person.”.

(11)    In regulation 20(2)(a) for “a substance listed in Annex I or III to the Council Regulation” substitute “a Table 1 substance”.

(12)    In regulation 22(3) for “an Annex IV substance” substitute “a Table 2 substance”.

(13)    In regulation 34(6) for “Articles 5 and 14 of the Council Regulation” substitute “Articles 14(6) and 16 of Regulation 470/2009”.

(14)    After regulation 36 insert—

“37 Review

(1)    The Secretary of State must from time to time—

(a)    carry out a review of these Regulations;

(b)    set out the conclusions of the review in a report; and

(c)    publish the report.

(2)    In carrying out the review the Secretary of State must, so far as is reasonable, have regards to how Council Directive 96/22 and Council Directive 96/23 (which are implemented by these Regulations) are implemented in other member States.

(3)    The report must in particular—

(a)    set out the objectives intended to be achieved by these Regulations;

(b)    assess the extent to which the objectives have been achieved;

(c)    assess whether the objectives remain appropriate and, if so, the extent to which they could be achieved in a less burdensome way.

(4)    The first report under this regulation must be published before the end of the period of five years beginning with 6th May 2013.

(5)    Reports under this regulation are afterwards to be published at intervals not exceeding five years.”.

NOTES
Initial Commencement
Specified date

Specified date: 6 May 2013: see reg 1.

Medical Ethics94 Animal Testing94 Research94 Health Law94

Signature

Richard Benyon

Parliamentary Under Secretary

Department for Environment, Food and Rural Affairs

4th April 2013

EXPLANATORY NOTE

EXPLANATORY NOTE (This note is not part of the Regulations)

These Regulations amend the Animals and Animal Products (Examination for Residues and Maximum Residue Limits) Regulations 1997 (SI 1997/1729) (“the principal Regulations”) that provided for the enforcement of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (OJ No L 224, 18.8.1990, p 1).

That Council Regulation has now been replaced, and these Regulations make supplementary provision to provide for the enforcement of its successor, Regulation (EC) No 470/2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin (OJ No L 152, 16.6.2009, p 11).

In addition, these Regulations provide for the enforcement of Commission Regulation (EU) No 37/2010 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin (OJ No L 15, 20.1.2010, p 1).

Regulation 2 amends the principal Regulations so that the references to EU legislation are up to date.

Provision is also made for the review of the principal Regulations (regulation 2(14)).

A full Impact Assessment has not been prepared in respect of these Regulations as no impact on the private, voluntary or public sectors is foreseen.