Regulatory Updates
Feed additives
Distribution date: 30 August 2013
Regulation (EC) No 1831/2003, notified in G/SPS/N/EEC/165/Add.1 (19 November 2003), provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisations. After the European Food Safety Authority evaluation of new information on 3-acetyl-2,5-dimethylthiophene, its authorisation as a feed additive is denied. This denial is enacted by "Commission Implementing Regulation (EU) No 796/2013 of 21 August 2013 concerning the denial of authorisation of the substance 3-acetyl-2,5-dimethylthiophene as a feed additive" [OJ L 224, 21 August 2013, pp. 4-5]. This substance 3-acetyl-2,5-dimethylthiophene was also withdrawn from the list of authorised flavouring substances used in food by "Commission Regulation (EU) No 545/2013 of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene" [OJ L 163, 15 June 2013, pp.15-16], notified in G/SPS/N/EU/13/Add.2. http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_e.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_f.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Feed additives
Distribution date: 30 August 2013
Regulation (EC) No 1831/2003, notified in G/SPS/N/EEC/165/Add.1 (19 November 2003), provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting or denying such authorisations. After the European Food Safety Authority evaluation of new information on 3-acetyl-2,5-dimethylthiophene, its authorisation as a feed additive is denied. This denial is enacted by "Commission Implementing Regulation (EU) No 796/2013 of 21 August 2013 concerning the denial of authorisation of the substance 3-acetyl-2,5-dimethylthiophene as a feed additive" [OJ L 224, 21 August 2013, pp. 4-5]. This substance 3-acetyl-2,5-dimethylthiophene was also withdrawn from the list of authorised flavouring substances used in food by "Commission Regulation (EU) No 545/2013 of 14 June 2013 amending Annex I to Regulation (EC) No 1334/2008 of the European Parliament and of the Council as regards the flavouring substance 3-acetyl-2,5-dimethylthiophene" [OJ L 163, 15 June 2013, pp.15-16], notified in G/SPS/N/EU/13/Add.2. http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_e.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_f.pdf http://members.wto.org/crnattachments/2013/sps/EEC/13_3450_00_s.pdf
Products Covered:
Regulation Type: Addendum to Regular Notification
Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011
Distribution date: 29 August 2013
The document introduces amendments to adjust CU legislation to the WTO SPS Agreement. Point 2 of the CU Commission Decision No. 721 will be amended in accordance with Article 3.3 of the WTO SPS Agreement.
Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU No. 317 as of 18 June 2010; Common list of regulated products subject to quarantine control, adopted by the Customs Union Commission Decision on plant quarantine in the CU No. 318 as of 18 June 2010; Common list of goods subject to sanitary and epidemiological control, adopted by the Customs Union Commission Decision on application of sanitary measures in the CU No. 299 as of 28 May 2010.
Regulation Type: Regular notification
Draft of the Eurasian Economic Commission Collegium Decision on amendments to the Customs Union Commission Decision on application of international standards, recommendations and guidelines No. 721 as of 22 June 2011
Distribution date: 29 August 2013
The document introduces amendments to adjust CU legislation to the WTO SPS Agreement. Point 2 of the CU Commission Decision No. 721 will be amended in accordance with Article 3.3 of the WTO SPS Agreement.
Products Covered: Common list of goods subject to veterinary control, adopted by the Customs Union (CU) Commission Decision on application of veterinary and sanitary measures in the CU No. 317 as of 18 June 2010; Common list of regulated products subject to quarantine control, adopted by the Customs Union Commission Decision on plant quarantine in the CU No. 318 as of 18 June 2010; Common list of goods subject to sanitary and epidemiological control, adopted by the Customs Union Commission Decision on application of sanitary measures in the CU No. 299 as of 28 May 2010.
Regulation Type: Regular notification
Testing and Inspection of Food and Drugs Act
Distribution date: 27 August 2013
Testing laboratory management regulations under 6 different laws (including Food sanitation Act, Pharmaceutical Affairs Act, etc.) have been consolidated into a single Act. The key features of the new law are: - Establishment of 5-year master plan for food and drug testing performance improvement; - Designation and management of testing laboratories; - Establishment and operation of a laboratory data management system.
Products Covered: Testing laboratories (food, livestock product, drug, herbal medicine, medical device, cosmetics)
Regulation Type: Regular notification
Testing and Inspection of Food and Drugs Act
Distribution date: 27 August 2013
Testing laboratory management regulations under 6 different laws (including Food sanitation Act, Pharmaceutical Affairs Act, etc.) have been consolidated into a single Act. The key features of the new law are: - Establishment of 5-year master plan for food and drug testing performance improvement; - Designation and management of testing laboratories; - Establishment and operation of a laboratory data management system.
Products Covered: Testing laboratories (food, livestock product, drug, herbal medicine, medical device, cosmetics)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 pages in English).
Distribution date: 23 August 2013 | Final date for Comment: 20 September 2013
The Minimum Requirements for Biological Products is to be partially amended to add the standard for a blood product to be newly approved.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Partial amendment to the Minimum Requirements for Biological Products (1 pages in English).
Distribution date: 23 August 2013 | Final date for Comment: 20 September 2013
The Minimum Requirements for Biological Products is to be partially amended to add the standard for a blood product to be newly approved.
Products Covered: Drugs (HS: 30)
Regulation Type: Regular notification
Dean Foods Company and WhiteWave Foods Company; Filing of Food Additive Petition; Notice of petition
Distribution date: 21 August 2013
The Food and Drug Administration is announcing that we have filed a petition submitted by the Dean Foods Company and the WhiteWave Foods Company proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food. The food additive petition was filed on 27 June 2013.
Products Covered: Vitamin D2 and vitamin D3 as nutrient supplements in food
Regulation Type: Regular notification
Dean Foods Company and WhiteWave Foods Company; Filing of Food Additive Petition; Notice of petition
Distribution date: 21 August 2013
The Food and Drug Administration is announcing that we have filed a petition submitted by the Dean Foods Company and the WhiteWave Foods Company proposing that the food additive regulations be amended to provide for the expanded safe uses of vitamin D2 and vitamin D3 as nutrient supplements in food. The food additive petition was filed on 27 June 2013.
Products Covered: Vitamin D2 and vitamin D3 as nutrient supplements in food
Regulation Type: Regular notification
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