Tag Archives: Animal product

Animal by-products

Animal by-products

Outline of the Community (European Union) legislation about Animal by-products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal nutrition

Animal by-products

Document or Iniciative

Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002.

Summary

This Regulation facilitates the efficient management of animal by-products whilst maintaining the high level of protection that is currently in place against risks to public and animal health and to the environment.

Products concerned

This Regulation shall apply to:

  • animal by-products * and derived products * which are not intended for human consumption;
  • products intended for purposes other than human consumption:
    • products of animal origin which may be destined for human consumption;
    • raw materials for the production of products of animal origin.

End point in the manufacturing chain

This Regulation introduces the notion of an “end point” in the manufacturing of animal by-products, beyond which they are no longer subject to the rules governing this type of product, since potential risks have been eliminated. Instead, the general rules on product safety are to apply. As an example, where animal fat produced by an incinerating factory is processed and the product of that transformation is used to produce plastics, the probability that the final product might transmit a significant biological risk is very slight.

Essential guarantees for public and animal health

Products of animal origin may be used outside the food chain for various purposes: skins for leather production, powdered milk to feed animals, and blood products in diagnostic medical devices. Such by-products may be a vector of diseases affecting human beings or animals when they are used in animal feedingstuffs or to produce technical products.

This Regulation preserves the basic guarantees introduced in 2003 against such risks. In particular, it maintains:

  • a risk-based categorisation of animal by-products which determines whether they may be used as animal feedingstuffs, for the manufacture of technical products or for other purposes, or whether they must be destroyed;
  • an obligation for Member States and operators to ensure that animal by-products are collected and disposed of as soon as possible;
  • the exclusion of products that are unfit for hum an consumption from the feed chain for farmed animals; and lastly
  • a ban on feeding animals of one species with material derived from the same species (“intra-species recycling ban”).

A more coherent legal framework

Animal by-products are used to produce cosmetics, medicines and diagnostic medical devices. When they are used for the manufacture of such products, they are subject to other provisions of European law. Slaughterhouses, milk factories and other food establishments manufacturing animal by-products are already bound by European legislation on human food or animal feedingstuffs, and are the subject of inspections in this regard.

This Regulation aims at improving coherency between other provisions of European law and the health rules applying to animal by-products. The potential risks are tackled with respect to the appropriate legislation, which avoids operators being exposed to unnecessary constraints.

Being based on experience gained, this Regulation clarifies under which circumstances and in what way environmental legislation shall apply to operations involving animal by-products. This legislation applies for example where the spreading of manure as a fertiliser has effects on soil and the groundwater table.

Comitology

The current categorisation of animal by-products may now be amended by the Commission under the comitology procedure. Prior to any change, a scientific organisation such as the European Food Safety Authority (EFSA) or the Scientific Committee for Consumer Products (SCCP) must assess the possible risks of a specific animal by-product for public and animal health.

Repeal

Regulation (EC) No 1774/2002 shall be repealed with effect from 4 March 2011.

Key terms of the Act
  • Animal by-products: entire bodies or parts of animals, products of animal origin or other products obtained from animals, which are not intended for human consumption, including oocytes, embryos and semen.
  • Derived products: products obtained from one or more treatments, transformations or steps of processing of animal by-products.
Act Entry into force Deadline for transposition in the Member States Official Journal

Regulation (EC) No 41/2009

10.2.2009

OJ L 16 of 21.1.2009

Trade in seal products

Trade in seal products

Outline of the Community (European Union) legislation about Trade in seal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Food safety > Animal welfare

Trade in seal products

Document or Iniciative

Regulation (EC) No 1007/2009 of the European Parliament and of the Council of 16 September 2009 on trade in seal products.

Summary

Following concerns expressed by citizens regarding seal hunting methods, this regulation harmonises existing national rules regarding the placing on the European Union (EU) market of seal products *.

The placing on the Union market of seal products is only allowed when they:

  • result from seal hunts traditionally conducted by Inuit * and other indigenous communities and contribute to their subsistence;
  • result from by-products of hunting that is regulated by national law, undertaken solely for the purpose of the sustainable management of marine resources. The placing on the market is only allowed on a non-profit basis.

The import of seal products for non-commercial reasons is allowed where it is of an occasional nature and consists exclusively of goods for the personal use of travellers or their families.

EU countries are responsible for laying down the rules on penalties for infringements of this regulation and must ensure an effective implementation of the applicable penalties.

Every four years EU countries must send a report to the Commission detailing the actions taken to implement this regulation.

Background

The regulation supplements existing EU legislation regarding the protection of seals, in particular Directive 83/129/EEC prohibiting the importation into EU countries of skins of certain seal pups.

Animal welfare protection is an objective pursued by the Commission and is the focus of a Protocol annexed to the EC Treaty (Protocol No 33), which is at the heart of the Action Plan on the Protection and Welfare of Animals for the period 2006-2010.

Key terms of the Act
  • Seal: specimens of all species of pinnipeds.
  • Seal product: all products, either processed or unprocessed, deriving or obtained from seals, including meat, oil, blubber, organs, raw fur skins and fur skins, tanned or dressed, including fur skins assembled in plates, crosses and similar forms as well as articles made from seal fur skins.
  • Inuit: indigenous members of the Inuit homeland, namely those arctic and subarctic areas where Inuit have aboriginal rights and interests, recognised by Inuit as being members of their people.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 1007/2009

20.11.2009

OJ L 286 of 31.10.2009

Related Acts

Commission Regulation (EU) No 737/2010 of 10 August 2010 laying down detailed rules for the implementation of Regulation (EC) No 1007/2009 of the European Parliament and of the Council on trade in seal products [Official Journal L 216 of 17.8.2010].

Residues of veterinary medicinal products in foodstuffs of animal origin

Residues of veterinary medicinal products in foodstuffs of animal origin

Outline of the Community (European Union) legislation about Residues of veterinary medicinal products in foodstuffs of animal origin

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Residues of veterinary medicinal products in foodstuffs of animal origin

Document or Iniciative

Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 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 (Text with EEA relevance).

Summary

This Regulation aims at defining the rules and procedures to be applied when setting maximum residue limits for medicinal products in foodstuffs of animal origin in order to guarantee food safety.

Scope

This Regulation establishes on the one hand the maximum concentration of a residue of a pharmacologically active substance which may be permitted in foodstuffs of animal origin and on the other defines the level of residues of medicinal products for which a maximum limit has not yet been set.

Active principles of biological origin used in immunological veterinary medicinal products and substances covered by the Regulation on contaminants in foodstuffs for human consumption are excluded from its scope.

Maximum residue limits

Substances intended for use in veterinary medicinal products

The European Medicines Agency issues an opinion on any application relating to a pharmacologically active substance intended for use in veterinary medicinal products. This opinion consists of a scientific risk assessment and risk management recommendations. The Agency ensures that the final opinion of the Committee is given within 210 days.

Other substances requiring an opinion from the Agency

The European Commission or Member States may submit to the Agency a request for an opinion on maximum residue limits in the following cases:

  • the use of the substance in question is authorised in a third country but has not been subject to an application for the establishment of a maximum residue limit by the Agency;
  • the substance in question is contained in a medicinal product but has not been subject to an application for the establishment of a maximum residue limit by the Agency.

The Agency shall ensure that the opinion of the Committee concerning a relevant request from the European Commission or Member States is given within 210 days.

Once the opinions have been published, the Commission, in consultation with the Agency, Member States and interested parties, shall adopt the following measures:

  • methodological principles to be applied following the risk assessment and recommendations described above;
  • rules concerning the use of a maximum residue limit for medicinal products.

Classification

The Commission classifies the pharmacologically active substances which have already been subject to an opinion from the Agency. This classification includes a list of pharmacologically active substances and the therapeutic classes to which they belong, as well as the following:

  • a maximum residue limit;
  • a provisional maximum residue limit (for a period not exceeding five years);
  • the absence of the need to establish a maximum residue limit;
  • a prohibition on the administration of a substance.

A maximum residue limit may be provided if scientific data is incomplete, as long as the substance does not constitute a hazard to human health. It is presupposed that the residues do not constitute a hazard to the health of individuals.

It is possible to obtain an emergency authorisation for a veterinary medicinal product or biocide product by making an application to the Agency to carry out an accelerated procedure for the assessment of the maximum residue limit. The Agency shall ensure that the final opinion of the Committee is given within 120 days.

Reference points for action

The Commission can establish reference points for action for residues of pharmacologically active substances which are not classified.

Reference points for action are established in consultation with official control laboratories in accordance with a method corresponding to Community requirements.

A request for a risk assessment may be sent to the European Food Safety Authority (EFSA) in order to determine whether the reference points for action are adequate.

Various provisions

The Agency consults Community reference laboratories using analytical methods which are appropriate for analysing residues. The aim of this consultation is also to achieve harmonised controls in order to provide information on the methods used during the authorisation procedure for official control laboratories.

When placed on the market, foodstuffs of animal origin which contain residues of medicinal products at a level exceeding the limit established by this Regulation or containing an unclassified substance are not considered as complying with the legislation.

This Regulation repeals Regulation (EC) No 2377/90. The Commission includes pharmacologically active substances and their classification from Regulation (EC) No 2377/90 in Annexes I to IV.

References

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EC) No 470/2009

6.7.2009

OJ L 152 of 16.6.2009

Related Acts

Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin [Official Journal L 15 of 20.1.2010].