Regulatory Updates

Draft Regulation of the European Parliament and of the Council amending Regulation (EC) No 999/2001 as regards the extension of the period for transitional measures (Doc.SANCO/3663/2002 – Available in English - 4 pages)

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Distribution date: 03 March 2003

The proposal notified hereby extends until 30 June 2005, the period for transitional measures foreseen by article 23 of Regulation 999/2001 to permit the changeover to this regulation. Further Background In notification G/SPS/N/EEC/72 (16 April 1999) the EC informed of a proposal ending in: Regulation 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. (OJ. L147, 31/05/2001, pp:1-40). This regulation set rules for the determination of the "BSE status" of a country from what it follows certain measures for the control of BSE as well as of the import/export trade. Article 23 of this regulation foresees the introduction of transitional measures prior to the determination of the BSE status of a country. In notification G/SPS/N/EEC/133 (3 August 2001) the EC informed of a proposal ending in Regulation 1326/2001 of 29 June 2001 laying down transitional measures to permit the changeover to the Regulation of the European Parliament and of the Council No 999/2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, and amending Annexes VII and XI to that Regulation (OJ L177, 30/06/01 pp.60-67). According to this regulation transitional measures were adopted which expire on the 30 June 2003.

Products Covered: Live bovine ovine and caprine (CN 0102 & 0104). Meat: fresh or frozen -of bovines (0201, 0202), ovine and caprine (0204); minced (020230, 02042300, 020443, 020450) or in preparations (1606). Edible offal of bovine animals fresh, chilled or frozen (0206); salted, in brine, dried or smoked; edible flours and meals of meat or meat offal (0210 20), guts, bladders and stomachs of bovine ovine and caprine animals (0504). Bovine casings (05040000) and products that may contain them. Raw material for the manufacture of feedingstuffs (0210.90). Bones (05606) and bone products (3503, 0210 & 2301). Rendered fats - bovine, ovine and caprine - (1502, 1506 & 1518). Meat preparations including extracts of bovine, ovine and caprine (1601 and 1602), including food preparation containing meat (1902). Gravies ("greaves") for human consumption of bovine, ovine and caprine origin (2301). Pet-food (2309). Processed animal protein in positions 0210 and 2301. Gelatine and derivatives (3503).

Regulation Type: Regular notification

Animal diseases Food safety Animal health Human health Zoonoses Bovine Spongiform Encephalopathy (BSE) Transmissible Spongiform Encephalopathy (TSE)

Resolution number 13, January 17th, 2003 (Resolução RDC no. 13, de 17 de janeiro de 2003) issued by the Brazilian Sanitary Surveillance Agency on Products destined for dentin hypersensibility. (1 page, in Portuguese).

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Distribution date: 20 February 2003

Products Covered: Products destined for dentin hypersensibility (HS: 33.06)

Regulation Type: Regular notification

Labelling

Draft Decree on In Vitro Diagnostic Medical Devices (45 pages, the draft is available in Hungarian).

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Distribution date: 20 February 2003

Products Covered: In vitro diagnostic medical devices: VI. - Chemical products, Chapter 30, 3006

Regulation Type: Regular notification

Decree 12/2002. (XI. 16.) ESZCSM of the Minister of Health, Social and Family Affairs on protection against carcinogenic substances of occupational origin and on the prevention of health damage caused by such substances, amending decree 26/2000. (IX. 30.) EüM of the Minister of Health (6 pages, decree is available in Hungarian).

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Distribution date: 20 February 2003

Products Covered: Mineral materials, asbestos: 2524 00; chemical materials, vinyl-chloride:  2903 21

Regulation Type: Regular notification

Draft Resolution number 99, December 16th, 2002 (Consulta Pública no. 99 de 16 de dezembro de 2002) issued by the Brazilian Sanitary Surveillance Agency on registration, amendments, post registration inclusion and validation of allergenic products. (20 pages, in Portuguese).

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Distribution date: 04 February 2003

Products Covered: Allergenic products (HS: 30.03 , 30.04)

Regulation Type: Regular notification

Labelling

Ministerial Act number 001, January 8th 2003 (Portaria no. 001 de 8 de janeiro de 2003), issued by Inmetro, on the labelling requirements for crepe bandages, orthopaedic bandages, gauze compresses and pre-washed surgery filed compresses. (2 pages, in Portuguese).

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Distribution date: 30 January 2003

Products Covered: Crepe bandages, orthopaedic bandages, gauze compresses and  pre-washed surgery filed compresses (HS: 30.05)

Regulation Type: Regular notification

Draft Resolution number 100, December 16th, 2002 (Consulta Pública no. 100 de 16 de dezembro de 2002) issued by the Brazilian Sanitary Surveillance Agency relative to a Mercosur Draft Resolution on nutritional labelling requirements for packaged food. (2 pages, in Portuguese).

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Distribution date: 30 January 2003

Products Covered: Packaged food (HS: Section IV)

Regulation Type: Regular notification

Food standards Labelling Nutrition information

Resolution number 298, 6 November 2002 (Resolução RDC no. 298, de 6 de novembro de 2002) issued by the Brazilian Sanitary Surveillance Agency on ganglioside-based drugs. (4 pages, in Portuguese).

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Distribution date: 13 January 2003

Products Covered: Ganglioside-based drugs (HS Chapter 30)

Regulation Type: Regular notification

Labelling

Notification of the Ministry of Commerce on Exportation and Importation of Caffeine B.E.2545(2002) (1 page, available in Thai language)

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Distribution date: 09 January 2003

Notification of the Ministry of Commerce on Exportation and Importation of Caffeine B.E.2545(2002) dated 25 June 2002 is withdrawn. This ministerial notification prescribes that caffeine and its salts are goods subject to import licensing and export approval. Caffeine derivatives and medicaments containing caffeine which are approved for importation and registration by the Food and Drug Administration, Ministry of Public Health are excluded.

Products Covered: Caffeine and its salts (HS Chapter 2939.30, ICS:  67.140.20), Medicaments containing alkaloids or derivatives thereof but not containing hormones of other products of heading No. 29.37 or antibiotics (HS Chapter 3003.40)

Regulation Type: Regular notification

Rule of the Ministry of Commerce on Criteria, Procedures and Conditions for Exportation and Importation of Caffeine B.E.2545(2002) (2 pages, available in Thai language)

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Distribution date: 09 January 2003

Rule of the Ministry of Commerce on Criteria, Procedures and Conditions for Exportation and Importation of Caffeine B.E.2545(2002) dated 25 June 2002 is withdrawn. This ministerial rule prescribes that application for approval shall be submitted together with: (1) Documented requests for exportation of such products or certificates of importation issued by the Food and Drug Administration (FDA), Ministry of Public Health or the Department of Industrial Works, Ministry of Industry, as the case may be. (2) Invoice or proforma invoice or other documents demonstrating trade arrangement.

Products Covered: Caffeine and its salts (HS Chapter 2939.30, ICS:  67.140.20), Medicaments containing alkaloids or derivatives thereof but not containing hormones of other products of heading No. 29.37 or antibiotics (HS Chapter 3003.40)

Regulation Type: Regular notification

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