Animal By-products derived from animals which have been administered with Veterinary medicines and certain other substances.
On this page:
- Information
- What is stated in legislation?
- What is meant by permitted levels?
- What is meant by Illegal treatment?
- Which ABP Category applies?
- Summary
Information
The EU Animal By-Products Regulation (EC) No. 1069/2009 classifies animal by-products (ABPs) into three categories based on their potential risk to animals or the public and sets out how ABPs in each category must be processed or disposed.
This guidance is intended to clarify which animal by-products fall under Articles 8 (c) and (d) (highest risk Category 1) and Article 9 (c) (Category 2) of the EU Regulation – i.e. ABPs from animals which have been submitted to illegal treatment or ABPs which contain residues exceeding permitted levels of certain substances such as veterinary drugs, other substances or environmental contaminants.
What is stated in legislation?
1. The EU Animal By-Products Regulation (EC) No. 1069/2009
Article 8(c) of the EU Animal By-Products Regulation states that Category 1material includes:
“Animal by-products derived from animals which have been submitted to illegal treatment as defined in Article 1(2)(d) of Directive 96/22/EC or Article 2(b) Directive 96/23/EC.”
Article 8(d) states that Category 1 material includes:-
“Animal by-products containing residues of other substances and environmental contaminants listed in Group B(3) of Annex I to Council Directive 96/23/EC, if such residues exceed the permitted level laid down by Community legislation or, in the absence thereof , by national legislation.”
Article 9 (c) states that Category 2 material includes –
“Animal by-products containing residues of authorised substances or contaminants exceeding the permitted levels as referred to in Article 15(3) of Directive 96/23/EC.”
Article 3 of Directive 96/22/EC prohibits the administering to a farm or aquaculture animal, by any means whatsoever, of substances having a thyrostatic, oestrogenic, androgenic or gestagenic action and of beta-agonists. There are some exceptions to this prohibition (see the attached Annex).
Annex I to Directive 96/23 reads —
GROUP A - Substances having anabolic effect and unauthorized substances
(1) Stilbenes, stilbene derivatives, and their salts and esters
(2) Antithyroid agents
(3) Steroids
(4) Resorcylic acid lactones including zeranol
(5) Beta-agonists
(6) Compounds included in Annex IV to Council Regulation (EEC) No 2377/90 of 26 June 1990
GROUP B - Veterinary drugs (1) and contaminants
(1) Antibacterial substances, including sulphonomides, quinolones
(2) Other veterinary drugs
(a) Anthelmintics
(b) Anticoccidials, including nitroimidazoles
(c) Carbamates and pyrethroids
(d) Sedatives
(e) Non-steroidal anti-inflammatory drugs (NSAIDs)
(f) Other pharmacologically active substances
(3) Other substances and environmental contaminants
(a) Organochlorine compounds including PcBs
(b) Organophosphorus compounds
(d) Chemical elements
(d) Mycotoxins
(e) Dyes
(f) Others
What is meant by permitted levels?
Article 8(d) refers to residues which exceed the permitted level laid down by Community legislation or, in the absence thereof, by national legislation. There is a similar reference in Article 9(c). The Community legislation that these provisions refer to is Council Directive 2377/90/EEC which lays down permitted residues in animals intended for human consumption and which is incorporated into UK law by the Maximum Residues Levels Regulations.
What is meant by Illegal treatment?
Article 2(b) of council directive 96/23/EC defines Illegal treatment as the use of unauthorised substances or products or the use of substances or products authorised under Community legislation for purposes or under conditions other than those laid down in community legislation or where appropriate, in the various national legislations;
Which ABP Category applies?
Whether or not there is a contaminant, it is necessary to establish whether the ABP is from an animal to which -
- a substance having a thyrostatic, oestrogenic, androgenic or gestagenic action; or
- a beta-agonist
has been administered.
Unless it has been administered under one of the exceptions to the prohibition in Article 3 of Directive 96/22/EC (see the attached Annex), it is Category 1 material.
If the ABP is not derived from such an animal, and there is a contaminant, it is necessary to check the lists in Annex I to Directive 96/23/EC to see if is listed in Groups A or B of that Annex. If it is, check whether it -
a) is in contravention of the prohibitions in Directive 96/23 (such as stilbenes); or
b) is in excess of the limits specified in Annexes I to III in Council Regulation (EEC) No. 2377/90; or
c) is contained in Annex IV of that Regulation.
If it is, it is Category 2 material.
If it is not Category 2 material, it is necessary to check whether it is in Group B(3), which logically it must be because of the word “others” at the end of the list in Group B(3).
The next test is whether or not the contaminant is in breach of EU legislation or, failing that, UK legislation. If it is, the material containing the contaminant is in Category 1. If it is not, it is not Category 1 and (assuming it is not Category 2, as above), will be Category 3 material.
Summary
In summary, it is considered that if the ABPs are from animals that have been administered substances in contravention of Directive 96/22/EC, they are Category 1 material irrespective of whether there is any residue from those substances. The fact that the animal has had the substance administered automatically means that it is Category 1.
If the by-products are from animals which have not had such substances administered, then
a) if the ABPs have no residues that are controlled by Council Regulation (EEC) No. 2377/90 or by domestic legislation, they will be Category 3 material.
b) if the ABPs have residues that are controlled by Council Regulation (EEC) No. 2377/90 or by domestic legislation, but the residues are below the levels specified in that legislation, the material is also Category 3.
c) if the ABPs have residues which are controlled by Council Regulation (EEC) No. 2377/90 or by domestic legislation, and the residues are above the levels specified in that legislation, then —
- if the residues are specified in Group A, B(1) or B(2) of Directive 96/23/EC, the material is category 2; and
- otherwise the material is category 1.
Annex
Exceptions to the prohibition in Article 3 of Directive 96/22/EC
The prohibition in Article 3 of Directive 96/22/EC does not apply to –
(a) the administering to farm animals, for therapeutic purposes, of testosterone and progesterone and derivatives which readily yield the parent compound on hydrolysis after absorption at the site of application. Veterinary medicinal products used for therapeutic treatment must comply with the requirements for placing on the market laid down in Directive 81/851/EEC (now 2001/82) and be administered only by a veterinarian, by injection or for the treatment of ovarian dysfunction in the form of vaginal spirals, but not by implant, to farm animals which have been clearly identified; or
(b) the administering to farm animals, for the purpose of zootechnical treatment, of veterinary medicinal products having an oestrogenic, androgenic or gestagenic action which are authorized in accordance with Directives 81/851/EEC and 81/852/EEC (now 2001/82)(i.e. authorised veterinary medicinal products). Such veterinary medicinal products must be administered by a veterinarian to clearly identified animals; the treatment must be recorded by the veterinarian responsible. However, Member States may allow the synchronization of oestrus and the preparation of donors and recipients for the implantation of embryos to be effected not by the veterinarian direct, but under his responsibility. With regard to aquaculture animals young fish may be treated for the first three months for the purpose of sex inversion with veterinary medicinal products that have an androgenous action and are authorized in accordance with Directives 81/851/EEC and 81/852/EEC (now2001/82).
