Regulatory Updates

Distribution date: 21 April 2008

This notice announces the availability of EPA's revised risk assessments for the pesticide creosote. In addition, this notice solicits public comment on risk reduction options for creosote as well as solicits comments on the qualitative economic impacts analysis, (Phase 5 of 6-Phase Process). EPA is developing a Reregistration Eligibility Decision (RED) for creosote through the full, 6-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.

Products Covered: Creosote, a restricted use pesticide, is a "heavy duty wood preservative" that was first registered in the United States in 1948. Presently, 13 products are registered as industrial wood preservatives for above and ground wood protection treatments, as well as wood used in marine environments.

Regulation Type: Regular notification

Distribution date: 21 April 2008

The Food and Drug Administration (FDA) is amending its regulations on the use of materials derived from cattle in human food and cosmetics.

Products Covered: Human foods, cosmetics (HS 33-3, 2106) (ICS 71.100, 67.040, 07.100)

Regulation Type: Regular notification

Distribution date: 18 April 2008

Products Covered: Poisonous or Deleterious substances: Benzenesulfonyl chloride(HS:29), 1,3-Dichloropropan-2-ol (HS:29), 2Mercaptoethanol (HS:29) , Isobutyl nitrite (HS:29) , Isopentyl nitrite(HS:29), 2(Dimethylamino)ethyl methacrylate (HS:29), 1-Bromo-3-chloropropane (HS:29)

Regulation Type: Regular notification

Distribution date: 15 April 2008

Products Covered: Drugs  (HS:  Chapter 30)

Regulation Type: Regular notification

Distribution date: 11 April 2008

To amend the specification, scope and application standards of food additives kaolin, talc, sodium carbonate, sunset yellow FCF, allura red AC, titanium dioxide, citric acid, and isomalt.

Products Covered: Kaolin, talc, sodium carbonate, sunset yellow FCF, allura red AC, titanium dioxide, citric acid, isomalt

Regulation Type: Regular notification

Distribution date: 10 April 2008

The Food and Drug Administration (FDA) invites public comment on the petition proposing that the color additive regulations be amended to increase the permitted use level of bismuth citrate as a color additive in cosmetics intended for hair coloring products on the scalp.

Products Covered: Hair Dyes (HS:  32-US1; ICS:  71.100)

Regulation Type: Regular notification

Distribution date: 09 April 2008

The Unsafe Goods (Tian Mao Panda Water Colour Paint Sets) Notice 2008 bans the importation and supply of water colour paint sets with the Tian Mao Panda brand mark. This brand of water colour paint sets has been found to contain excessive levels of lead and chromium.

Products Covered: Artists' paint sets (HS:  321310)

Regulation Type: Regular notification

Distribution date: 03 April 2008 | Final date for Comment: 02 June 2008

The proposal sets new maximum levels for lead, cadmium and mercury in food supplements. For lead a maximum level of 3.0 mg/kg for all food supplements is proposed. For cadmium a maximum level of 1.0 mg/kg is proposed for all food supplements, excl. food supplements consisting exclusively or mainly of dried seaweed or of products derived from seaweed. For the latter group a maximum level of 3.0 mg/kg is proposed. For mercury a maximum level of 0.10 mg/kg for all food supplements is proposed.

Products Covered: Food supplements, understood as numerous food products used as complement to normal diet, normally circulating under Chapters 21, 29 and 30, mostly under headings 2106, 2109, 3004)

Regulation Type: Regular notification

Distribution date: 03 April 2008

The EC is notifying hereby a "Draft Commission Regulation amending Annexes VIII, X and XI to Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the import of blood products for the manufacture of technical products" (SANCO/10402/2007 Rev.5, available in English, 16 pages). The aim of the proposal is to facilitate trade of blood products. Further details are provided below. Background: Regulation 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption (O. J. L273, 10 October 2002 pp. 1-95, notified in G/SPS/N/EEC/103 dated 24 November 2000) provides for rules concerning the means of disposal and uses of animal by-products, including blood and blood fractions which are destined for uses other than human consumption. This regulation has received numerous comments concerning the trade on blood and blood fractions for uses other than human consumption such as animal feed or technological uses; in response to these comments and following more up to date risk analysis, the following two actions have been taken: As regards to heat-treated blood fractions from non-ruminant animals which have undergone ante-mortem inspection, in Document SANCO/10586/2006 Rev.6 (notified in G/SPS/N/EEC/103 Add.20 dated 21 November 2007) the Commission clarified its legal status by qualifying them as bloodmeal normally circulating under HS subheading 2301, and extended the heat-treatments to blood fractions which are already applicable to whole blood. The proposal notified thereby "Commission Regulation amending Annexes I, V and VII to Regulation (EC) No. 1774/2002 of the European Parliament and of the Council laying down health rules concerning animal by-products not intended for human consumption", will be adopted and published soon. As regard to animal blood for technological uses, normally circulating under HS subheading 30.02 the regulation only allows imports when the country or region of origin is free from certain diseases without vaccination, furthermore it excluded imports of blood from animals treated with certain substances having a hormonal or thyrostatic action and of ß-agonists. This proposal: Following more up to date scientific advice, the European Commission is proposing: 1. to delete the condition of that blood products of ruminant are allowed only if region of origin must be eligible for the import of live animals into the Community; 2. to allow imports of untreated blood products of ruminants from countries or regions which are free from foot and mouth disease with vaccination under condition of that imported blood is channelled to their place of destination under secure conditions for further processing; 3. to extend the lists of third countries authorised to export blood products intended for technical purposes, to include countries which are able to comply with the treatment requirements (Separate health certificates are laid down for treated and untreated blood products); 4. to allow the imports of into the Community of blood derived from animals treated with certain substances having a hormonal or thyrostatic action and of ß-agonists; and 5. to update the requirements related to the import of blood products from poultry and other avian species by referring to the international standards laid down in the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE). Other relevant documents: A consolidated version (date of reference 1 January 2007) of regulation 1774/2002 in English, French and Spanish is available from the hyperlink indicated below: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002R1774:20070101:EN:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002R1774:20070101:FR:PDF http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:2002R1774:20070101:ES:PDF or http://members.wto.org/crnattachments/2008/sps/EEC/08_1001_00_e.pdf More information on import conditions for materials of animal origin not intended for human consumption to the EC can be obtained in the hyperlink indicated below: http://ec.europa.eu/food/food/biosafety/animalbyproducts/index_en.htm Proposed date of adoption: As soon as possible Proposed date of application: Cannot be foreseen now. Most probably six month after the date of adoption. Final date for comments: This is a trade facilitation measure. Comment period does not apply. 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: 31 March 2008 | Final date for Comment: 07 April 2008

The notified regulation opens a 30-days period for public consultation on the draft normative instruction that approves the definitions and standards on the specifications, guarantees, tolerances, registration, packaging and labeling of organic fertilizers - simple, mixed, compounds, mineral-organic fertilizers and biofertilizers for agriculture.

Products Covered: Organic fertilizers - simple, mixed and compounds, mineral-organic fertilizers and biofertilizers for agriculture

Regulation Type: Regular notification