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

Distribution date: 08 November 2005

It is proposed to enlarge the EC list of chemical substances that may be used in the manufacture of foods for particular nutritional uses (FPNU). Substance Category of food All FPNU FSMP calcium-L-methylfolate x magnesium L-aspartate x boric acid x sodium borate x creatine monohydrate x FSMP: Foods for special medical purposes.FPNU: Dietary foods for particular nutritional uses including FSMP’s but excluding infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children. Further background: In G/SPS/N/EEC/80 (6 April 2000) the EC notified Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (O.J. L52, 22/02/2001 pp. 19-5) that specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of FPNU. In G/SPS/N/EEC/229 (23 December 2003) the EC notified Commission Directive 2004/5/EC of 20 January 2004 amending Directive 2001/15/EC to include certain substances in the Annex (O.J. L14, 21/01/2004 pp.: 19 -20) Since 2004, additional substances have been evaluated and the measure proposed hereby includes them in the annex to Directive 2001/15/EC.

Products Covered: Foodstuffs for particular nutritional uses (i.e. foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability). CN Headings 2104, 2106. ICS: 67.040, 677.220.20 and 67.2300

Regulation Type: Regular notification

Distribution date: 08 November 2005

It is proposed to enlarge the EC list of chemical substances that may be used in the manufacture of foods for particular nutritional uses (FPNU). Substance Category of food All FPNU FSMP calcium-L-methylfolate x magnesium L-aspartate x boric acid x sodium borate x creatine monohydrate x FSMP: Foods for special medical purposes.FPNU: Dietary foods for particular nutritional uses including FSMP’s but excluding infant formulae, follow-on formulae, processed cereal-based foods and baby foods intended for infants and young children. Further background: In G/SPS/N/EEC/80 (6 April 2000) the EC notified Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (O.J. L52, 22/02/2001 pp. 19-5) that specifies certain categories of substances and mentions for each of them the chemical substances that may be used in the manufacture of FPNU. In G/SPS/N/EEC/229 (23 December 2003) the EC notified Commission Directive 2004/5/EC of 20 January 2004 amending Directive 2001/15/EC to include certain substances in the Annex (O.J. L14, 21/01/2004 pp.: 19 -20) Since 2004, additional substances have been evaluated and the measure proposed hereby includes them in the annex to Directive 2001/15/EC.

Products Covered: Foodstuffs for particular nutritional uses (i.e. foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability). CN Headings 2104, 2106. ICS: 67.040, 677.220.20 and 67.2300

Regulation Type: Regular notification

Distribution date: 03 November 2005

The Ministry of Public Health (MOPH) proposes to allow Stevia plant and parts thereof as raw materials for herbal tea except for crude extracted other than from water and its derivatives other than stevioside and also to unify the previous MOPH notifications No. 154 and 261 regarding certain chemical substances prohibited from production, import or sale.

Products Covered: Prohibited Chemical Substances (ICS 67.140.10, 67.220.20)

Regulation Type: Regular notification

Distribution date: 03 November 2005

The Ministry of Public Health (MOPH) proposes to allow Stevia plant and parts thereof as raw materials for herbal tea except for crude extracted other than from water and its derivatives other than stevioside and also to unify the previous MOPH notifications No. 154 and 261 regarding certain chemical substances prohibited from production, import or sale.

Products Covered: Prohibited Chemical Substances (ICS 67.140.10, 67.220.20)

Regulation Type: Regular notification

Distribution date: 02 November 2005

EPA is proposing an exemption to the phaseout of methyl bromide production and import for 2006 critical uses. Specifically, EPA is proposing uses that will qualify for the 2006 critical use exemption, and the amount of methyl bromide that may be produced, imported, or made available from stocks for those uses in 2006. EPA's action is taken under the authority of the Clean Air Act and reflects recent consensus Decisions taken by the Parties to the Montreal Protocol on Substances that Deplete the Ozone Layer (Protocol) at the 16th Meeting of the Parties (MOP) and the 2nd Extraordinary Meeting of the Parties (ExMOP). EPA is seeking comment on both the list of critical uses, and on EPA's determination of the amounts of methyl bromide needed to satisfy those uses.

Products Covered: Ozone Depleting Substances (HS Chapter 3808) (ICS:  13)

Regulation Type: Regular notification