Regulatory Updates

Distribution date: 30 October 2008

Products Covered: Tobacco products (HS:  240310; ICS:  65.160)

Regulation Type: Regular notification

Distribution date: 30 October 2008

Products Covered: Milk and Milk products

Regulation Type: Regular notification

Distribution date: 29 October 2008

La República de Colombia comunica con relación al Decreto Nº 3249 del 18 de septiembre de 2006 "Por el cual se reglamenta la fabricación, comercialización, envase, rotulado o etiquetado, régimen de registro sanitario, de control de calidad, de vigilancia sanitaria y control sanitario de los suplementos dietarios, se dictan otras disposiciones y se deroga el Decreto N° 3636 de 2005" del Ministerio de la Protección Social, notificado mediante el documento identificado con la signatura G/SPS/N/COL/98/Add.2 del 2 de noviembre de 2006, que éste ha sido modificado, mediante el Decreto Nº 3863 del 2 de octubre de 2007 del Ministerio de la Protección Social. Texto disponible en el Ministerio de Comercio, Industria y Turismo, Dirección de Regulación, Organismo Nacional encargado de la notificación:

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 15 October 2008 | Final date for Comment: 14 December 2008

To establish standards for benzo(a)pyrene in Rehmanniae Radix Preparata and Rehmannia glutinosa.

Products Covered: Food products

Regulation Type: Regular notification

Distribution date: 14 October 2008 | Final date for Comment: 13 December 2008

Draft regulation that establishes sanitary requirements for importation of bovine fetal serum.

Products Covered: Bovine fetal serum

Regulation Type: Regular notification

Distribution date: 14 October 2008 | Final date for Comment: 13 December 2008

Draft regulation that establishes sanitary requirements for importation of bovine blood plasma/serum.

Products Covered: Blood plasma/serum

Regulation Type: Regular notification

Distribution date: 08 October 2008

The US Food and Drug Administration published a final rule in the Federal Register on 29 September 2008 (73 FR 56477), amending the "Calcium and Reduced Risk of Osteoporosis" health claim (21 CFR 101.72) to: (1) include vitamin D so that in addition to a claim for calcium and reduced risk of osteoporosis, a claim can be made for calcium and vitamin D and reduced risk of osteoporosis; (2) eliminate the requirement that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (3) eliminate the requirements that the claim identify the populations at particular risk for the development of osteoporosis and that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general United States population; (4) eliminate the requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis; (5) eliminate the requirement that the claim include a statement that a total dietary intake greater than 200 percent of the recommended daily intake of calcium has no further benefit to bone health when the food contains 400 mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake; and (6) allow reference for the need of physical activity in the claim to be optional rather then required. This action is being taken to provide truthful, scientifically valid information to assist consumers in constructing healthier total daily diets. The complete text of the Final Rule in the Federal Register, (73 FR 56477) (available in English), can be found on the Internet at: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22730.pdf For information contact: Jillonne Kevala, Center for Food Safety and Applied Nutrition (HFS-830), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 03 October 2008

The Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners has been substantially amended several times [amendments notified in documents G/SPS/N/EEC/088 (27/06/2000), G/SPS/N/EEC/168 (3/07/2002), G/SPS/N/EEC/202 (17/06/2003), G/SPS/N/EEC/233 (26/01/2004) and lastly G/SPS/N/EEC/296 (03/10/2006)]. In the interest of clarity and rationality the said directive has been codified and adopted as "Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Codified version)" [OJ L253, 20 September 2008, pp.1-175]. The full text can be downloaded from the internet address indicated below http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:253:0001:0175:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:253:0001:0175:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2008:253:0001:0175:ES:PDF or http://members.wto.org/crnattachments/2008/sps/EEC/08_3156_e.pdf http://members.wto.org/crnattachments/2008/sps/EEC/08_3156_f.pdf http://members.wto.org/crnattachments/2008/sps/EEC/08_3156_s.pdf The notified document can be obtained from the EC Enquiry Point: sps@ec.europa.eu

Products Covered:

Regulation Type: Addendum to Regular Notification

Distribution date: 24 September 2008 | Final date for Comment: 10 November 2008

This draft technical regulation approves the inclusion of enzymes for food production for human consumption according to the Resolution Annex.

Products Covered: Enzyme

Regulation Type: Regular notification

Distribution date: 18 September 2008

Products Covered: KN-Code: 2710 19 41, KN-Code: 3824 90 91, KN-Code: 3824 90 97, KN-Codes: 2711 12 11 – 2711 19 00, KN-Code: 2711 21 00, HS: 1507 - 1518

Regulation Type: Regular notification