Commission Regulation (EU) 2015/1162
of 15 July 2015
amending Annex V to Regulation (EC) No 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
Regulation (EC) No 999/2001 lays down rules for the prevention, control and eradication of transmissible spongiform encephalopathies (TSEs) in animals. It applies to the production and placing on the market of live animals and products of animal origin and, in certain specific cases, to exports thereof.
Point 1 of Annex V to Regulation (EC) No 999/2001 designates as specified risk material (‘SRM’) certain bovine, ovine and caprine tissues if they come from animals whose origin is in a Member State or third country, or in one of their regions, with a controlled or undetermined Bovine Spongiform Encephalopathy (‘BSE’) risk status. Point 2 of that Annex extends the list of tissues designated as SRM to Member States with a negligible BSE risk status, but not to third countries with the same status. As a consequence, Member States with a negligible BSE risk status are to remove and dispose of SRM, while imports into the Union of such tissues from third countries with a negligible BSE risk status are allowed.
Authorising all bovine tissues currently classified as SRM to be used in the food chain in Member States with a negligible BSE risk status is considered premature at this stage due to certain remaining scientific uncertainties linked to Atypical BSE.
According to this joint opinion, several elements indicate that the L-type atypical BSE agent has the potential to be a zoonotic agent. By contrast, such elements are absent for the H-type atypical BSE agent. This joint opinion also stated that the unusually old age of all H-type atypical BSE and L-type atypical BSE identified cases and their apparent low prevalence in the population suggest that these Atypical BSE forms are arising spontaneously, independently of the animal feeding practices. The BSE surveillance system in the Union showed a very low prevalence and relative constant level of atypical BSE cases in recent years.
For all those reasons, the brain and the spinal cord of cattle over 12 months whose origin is in a Member State with negligible BSE risk status should remain in the list of SRM, pending further knowledge is gained on the risk linked to Atypical-BSE.
Given the practical difficulties to ensure the absence of contamination of the bones of the skull with brain tissues, the skull of cattle over 12 months whose origin is in a Member State with negligible BSE risk status should also be maintained as SRM.
The data examined by EFSA mainly refer to Europe, due to the very robust surveillance system in the EU. Discussions at OIE level are ongoing to review the BSE chapter of the OIE Terrestrial Animal Health Code in the light of recently acquired knowledge concerning Atypical-BSE. The Union rules as regards SRM in Member States and third countries with negligible BSE risk status should be reviewed in the light of the outcome of these discussions.
The skull, the brain, the spinal cord and the eyes of bovine animals over 12 months are not known to be imported into the Union.
In order to ensure more similar conditions for putting on the market commodities from the Member States compared to imports of commodities from third countries, while taking into account the possible remaining risk linked to the use in the food and/or feed chain of certain tissues, the additional requirement extending the prohibition of SRM of bovines to Member States with a negligible BSE risk should therefore be repealed except for the skull, the brain and spinal cord of bovine animals over 12 months.
Regulation (EC) No 999/2001 should therefore be amended accordingly.
Should future scientific evidence point out public health risks that are currently unknown, the Union rules as regards SRM in Member States and third countries with negligible BSE risk should be reviewed.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
In Annex V to Regulation (EC) No 999/2001, point 2 is replaced by the following:
‘2.Specific requirements for Member States with negligible BSE risk status
Tissues listed in point 1.(a)(i) and 1.(b), which are derived from animals whose origin is in Member States with a negligible BSE risk, shall be considered as specified risk material.’.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 July 2015.
For the Commission
The President
Jean-Claude Juncker