General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device (4 pages, in English).
Distribution date: 09 July 2007
The Food and Drug Administration (FDA) is proposing to reclassify the device, tissue adhesive for the topical approximation of skin, from class III (premarket approval) into class II (special controls). Tissue adhesives for non-topical uses would remain in class III and continue to require premarket approval applications (PMAs). FDA is proposing this reclassification in accordance with the Federal Food, Drug, and Cosmetic Act.
Products Covered: Tissue adhesive; (HS: 3006.10; ICS: 11.040)
Regulation Type: Regular notification
Rules amending the Rules on limit values of pesticide residues in/on foodstuffs and agricultural products (1 page, in Slovenian).
Distribution date: 09 July 2007
The change and supplement to the Rules will enable Slovenia to consider also the maximum pesticide residual levels (MRL) as defined nationally in other EU countries. In general, considering the uncertainty of the measurement of 50% that covers the inter-laboratory variability between the laboratories and is recommended to be used by regulatory authorities in cases of enforcement of the decision. Competence of the inspectors is defined more evidently.
Products Covered: HS: 3808; ICS: 65.100
Regulation Type: Regular notification
Live farm and aquaculture animals; meat and meat products (HS Chapters 01, 02, 03, 04, 16)
Distribution date: 03 July 2007
Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC. (OJ L 125, 23.5.1996, p. 3- 9) prohibits the use of oestradiol 17 and its ester like derivatives to include therapeutic and zootechnical use in farm animals as well as other five hormones (testosterone, progesterone, trembolone acetate, zeranol and melengestrol acetate) for growth promotion purposes in farm animals, on a provisional basis. The latest modification of this Directive was notified in Document G/SPS/N/EEC/102/Rev.1/Add.1 (dated 23 October 2003). A consolidated text (EN/FR/ES) is available from the links indicted below: http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1996/L/01996L0022-20031014-en.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/consleg/1996/L/01996L0022-20031014-fr.pdf http://eur-lex.europa.eu/LexUriServ/site/es/consleg/1996/L/01996L0022-20031014-es.pdf Now, the European Commission, in document COM(2007) 292 final, 2007/0102 (COD) notifies a Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists. This proposal prohibits completely the use of oestradiol 17β in food-producing animals and removes pet animals from the scope of the Council Directive 96/22/EC. The text (ENG/FRA/ESP) is available in the following links http://eur-lex.europa.eu/LexUriServ/site/en/com/2007/com2007_0292en01.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/com/2007/com2007_0292fr01.pdf http://eur-lex.europa.eu/LexUriServ/site/es/com/2007/com2007_0292es01.pdf Proposed date of adoption: End of 2008. Note: This proposal follows the co-decision procedure (Article 251 of the EC Treaty). Information of its progress through the European Parliament and the Council is available from Pre-Lex, at the links indicated below (ENG/FRA/ESP): http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=fr&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=es&DosId=195794 Proposed date of application: Cannot be given at this stage of the co-decision procedure (see above). Final date for comments: 60 days after date of notification
Products Covered:
Regulation Type: Addendum to Regular Notification
Live farm and aquaculture animals; meat and meat products (HS Chapters 01, 02, 03, 04, 16)
Distribution date: 03 July 2007
Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC. (OJ L 125, 23.5.1996, p. 3- 9) prohibits the use of oestradiol 17 and its ester like derivatives to include therapeutic and zootechnical use in farm animals as well as other five hormones (testosterone, progesterone, trembolone acetate, zeranol and melengestrol acetate) for growth promotion purposes in farm animals, on a provisional basis. The latest modification of this Directive was notified in Document G/SPS/N/EEC/102/Rev.1/Add.1 (dated 23 October 2003). A consolidated text (EN/FR/ES) is available from the links indicted below: http://eur-lex.europa.eu/LexUriServ/site/en/consleg/1996/L/01996L0022-20031014-en.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/consleg/1996/L/01996L0022-20031014-fr.pdf http://eur-lex.europa.eu/LexUriServ/site/es/consleg/1996/L/01996L0022-20031014-es.pdf Now, the European Commission, in document COM(2007) 292 final, 2007/0102 (COD) notifies a Proposal for a Directive of the European Parliament and of the Council amending Council Directive 96/22/EC concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyreostatic action and of beta agonists. This proposal prohibits completely the use of oestradiol 17β in food-producing animals and removes pet animals from the scope of the Council Directive 96/22/EC. The text (ENG/FRA/ESP) is available in the following links http://eur-lex.europa.eu/LexUriServ/site/en/com/2007/com2007_0292en01.pdf http://eur-lex.europa.eu/LexUriServ/site/fr/com/2007/com2007_0292fr01.pdf http://eur-lex.europa.eu/LexUriServ/site/es/com/2007/com2007_0292es01.pdf Proposed date of adoption: End of 2008. Note: This proposal follows the co-decision procedure (Article 251 of the EC Treaty). Information of its progress through the European Parliament and the Council is available from Pre-Lex, at the links indicated below (ENG/FRA/ESP): http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=en&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=fr&DosId=195794 http://ec.europa.eu/prelex/detail_dossier_real.cfm?CL=es&DosId=195794 Proposed date of application: Cannot be given at this stage of the co-decision procedure (see above). Final date for comments: 60 days after date of notification
Products Covered:
Regulation Type: Addendum to Regular Notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Withdrawal of the maximum residue limits for avoparcin (Feed additive and veterinary drug) on all commodities listed under Item 3.
Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk, chicken (muscle, fat, liver, kidney and other edible offal), other poultry (muscle, fat, liver, kidney and other edible offal)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Withdrawal of the maximum residue limits for avoparcin (Feed additive and veterinary drug) on all commodities listed under Item 3.
Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk, chicken (muscle, fat, liver, kidney and other edible offal), other poultry (muscle, fat, liver, kidney and other edible offal)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Establishment of maximum residue limits for veterinary drug, difloxacin, in foods
Products Covered: Pig (muscle, fat, liver, kidney and other edible offal)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Establishment of maximum residue limits for veterinary drug, difloxacin, in foods
Products Covered: Pig (muscle, fat, liver, kidney and other edible offal)
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Establishment of maximum residue limits for veterinary drug, dramectin, in foods.
Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk
Regulation Type: Regular notification
Revision of the standards and specifications for foods and food additives under the Food Sanitation Law (Additional establishment of residue limits for veterinary drug)
Distribution date: 29 June 2007 | Final date for Comment: 28 August 2007
Establishment of maximum residue limits for veterinary drug, dramectin, in foods.
Products Covered: Cattle (muscle, fat, liver, kidney and other edible offal), pig (muscle, fat, liver, kidney and other edible offal), other terrestrial mammals (muscle, fat, liver, kidney and other edible offal), milk
Regulation Type: Regular notification
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