Regulatory Updates

Distribution date: 16 November 2005

Products Covered: Complementary and herbal medicinal products

Regulation Type: Regular notification

Distribution date: 16 November 2005

Products Covered: Complementary and herbal medicinal products

Regulation Type: Regular notification

Distribution date: 16 November 2005

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 16 November 2005

Products Covered: Medicines

Regulation Type: Regular notification

Distribution date: 16 November 2005

Draft normative instruction that approves the “Technical regulation for research, development, production, evaluation, registration and permit renewal, trade and use of vaccine against canine visceral leishmaniasis.

Products Covered: Vaccine against Canine Visceral Leishmaniasis

Regulation Type: Regular notification

Distribution date: 16 November 2005

Draft normative instruction that approves the “Technical regulation for research, development, production, evaluation, registration and permit renewal, trade and use of vaccine against canine visceral leishmaniasis.

Products Covered: Vaccine against Canine Visceral Leishmaniasis

Regulation Type: Regular notification

Distribution date: 10 November 2005

Today the Environmental Protection Agency (EPA) is proposing to determine that HCFC-22 and HCFC-142b are unacceptable for use in the foam sector under the Significant New Alternatives Policy (SNAP) Program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a greater risk to public health and the environment than the substance they replace or than other available substitutes. Specifically, EPA is taking two actions. First, in response to a court decision upholding a challenge to EPA's July 2002 final rule finding HCFC-22 and HCFC-142b acceptable subject to Narrowed Use Limits in three foam end uses, we are proposing to find HCFC-22 and HCFC-142b unacceptable as substitutes for HCFC-141b in the foam end uses of commercial refrigeration, sandwich panels, slabstock and "other" foams. Second, in the July 2002 final rule, EPA withdrew a proposed action to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses. We are now issuing a new proposal to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses.

Products Covered: Ozone Depleting Substances (HS Chapter:  3824;  ICS:  13)

Regulation Type: Regular notification

Distribution date: 10 November 2005

Today the Environmental Protection Agency (EPA) is proposing to determine that HCFC-22 and HCFC-142b are unacceptable for use in the foam sector under the Significant New Alternatives Policy (SNAP) Program under section 612 of the Clean Air Act. The SNAP program reviews alternatives to Class I and Class II ozone depleting substances and approves use of alternatives which do not present a greater risk to public health and the environment than the substance they replace or than other available substitutes. Specifically, EPA is taking two actions. First, in response to a court decision upholding a challenge to EPA's July 2002 final rule finding HCFC-22 and HCFC-142b acceptable subject to Narrowed Use Limits in three foam end uses, we are proposing to find HCFC-22 and HCFC-142b unacceptable as substitutes for HCFC-141b in the foam end uses of commercial refrigeration, sandwich panels, slabstock and "other" foams. Second, in the July 2002 final rule, EPA withdrew a proposed action to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses. We are now issuing a new proposal to find HCFC-22 and HCFC-142b unacceptable as substitutes for CFCs in all foam end uses.

Products Covered: Ozone Depleting Substances (HS Chapter:  3824;  ICS:  13)

Regulation Type: Regular notification

Distribution date: 08 November 2005

It is proposed to add: Boric acid, Calcium-L-methylfolate and Sodium borate, to the list of forms of vitamins and minerals that may be used for the manufacture of food supplements Further background: In G/SPS/N/EEC/87 (16 June 2000) the EC notified Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (O. J. L183, 12/07/2002 pp. 51-57) that set EC rules for food supplements containing vitamins and minerals. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements. Since 2002, additional substances have been evaluated and are proposed to be included in the Annex.

Products Covered: Food supplements (foodstuffs aiming to supplement the normal diet consisting on concentrated sources of nutrients or substances with a nutritional effect). CN 2106, 2936 and 3044. ICS 67.220

Regulation Type: Regular notification

Distribution date: 08 November 2005

It is proposed to add: Boric acid, Calcium-L-methylfolate and Sodium borate, to the list of forms of vitamins and minerals that may be used for the manufacture of food supplements Further background: In G/SPS/N/EEC/87 (16 June 2000) the EC notified Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (O. J. L183, 12/07/2002 pp. 51-57) that set EC rules for food supplements containing vitamins and minerals. Only vitamins and minerals listed in Annex I, in the forms listed in Annex II, may be used for the manufacture of food supplements. Since 2002, additional substances have been evaluated and are proposed to be included in the Annex.

Products Covered: Food supplements (foodstuffs aiming to supplement the normal diet consisting on concentrated sources of nutrients or substances with a nutritional effect). CN 2106, 2936 and 3044. ICS 67.220

Regulation Type: Regular notification