Article 1
Annex III to Regulation (EC) No 853/2004 is amended as...
Article 2
This Regulation shall enter into force on the twentieth day...
Commission Regulation (EU) 2016/355
of 11 March 2016
amending Annex III to Regulation (EC) No 853/2004 of the European Parliament and of the Council as regards the specific requirements for gelatine, collagen and highly refined products of animal origin intended for human consumption
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin , and in particular Article 10(1) thereof,
Whereas:
(1)
Regulation (EC) No 853/2004 lays down specific rules on the hygiene of food of animal origin for food business operators. That Regulation provides in particular that food business operators are to ensure compliance with specific requirements for raw materials for the production of gelatine and collagen intended for human consumption.
(2)
It is necessary to ensure that raw materials for the production of gelatine and collagen for human consumption come from sources that meet the public and animal health requirements laid down in Union legislation.
(3)
The Union is highly dependent on imports of raw materials for the production of gelatine and collagen. Establishments producing those raw materials apply specific treatments to exclude public and animal health risks linked to those raw materials. It is therefore appropriate to allow those treatments prior to placing on the market in the Union.
(4)
It is appropriate to adapt the requirements for the production process for collagen to allow practical changes in cases where a change does not result in a different level of public health protection.
(5)
Analytical methods for verifying residue limits in gelatine and collagen should be adapted to the most appropriate and most recently validated methods.
(6)
In order to ensure the safety of certain highly refined products, to ensure the enforcement of EU provisions and to ensure fair competition as regards raw materials coming from within the Union and from third countries, it is appropriate to harmonise conditions and lay down specific requirements for the production of certain highly refined products of animal origin intended for human consumption. The import of other products of animal origin for which Annex III to Regulation (EC) No 853/2004 does not lay down specific requirements, remains allowed in accordance with Commission Regulation (EU) No 1079/2013 .
(7)
Annex III to Regulation (EC) No 853/2004 should therefore be amended accordingly.
(8)
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:
OJ L 139, 30.4.2004, p. 55.
Commission Regulation (EU) No 1079/2013 of 31 October 2013 laying down transitional measures for the application of Regulations (EC) No 853/2004 and (EC) No 854/2004 of the European Parliament and of the Council (OJ L 292, 1.11.2013, p. 10).