Regulatory Updates

Distribution date: 13 July 2011 | Final date for Comment: 11 September 2011

This ministerial notification withdraws, from the list of hazardous substances annexed to the Ministerial Notification of the Ministry of Industry Regarding List of Hazardous Substances dated 17 February B.E. 2538 (1995), the following substances, use of which remains under the supervision of the Department of Agriculture. ; - Non-chemically processed product from parts of plant used for preventing, eradicating, controlling insects, weeds, plant disease, or for plant growing control, namely neem, citronella, curcuma, ginger, galangal, marigold, bitter bush, tea seed cake, chili, celery, ringworm bush, climbing lily and Stemona tuberosa Lour. ;

Products Covered: Hazardous substances (HS: 29, ICS: 13.030.30)

Regulation Type: Regular notification

Distribution date: 07 July 2011

Several notifications and alerts have been received by the Rapid Alert System for Food and Feed concerning food contact materials imported into the Union from the People's Republic of China and Hong Kong Special Administrative Region of the People's Republic of China, releasing into food or food simulant amounts of chemicals that are not in compliance with the Union legislation. Article 48(2) of Regulation (EC) No 882/2004 provides for the possibility to impose specific import conditions on particular products coming from certain third countries, taking into account the risks associated with these products. This Regulation applies from 1 July 2011. The provisions of this Regulation should be periodically reviewed, taking into account the information received from the Member States.

Products Covered: Kitchenware of polyamide and of melamine consigned from China or Hong Kong, China (TARIC Code 3924.10.00.11); ICS Code: 97.190.

Regulation Type: Regular notification

Distribution date: 07 July 2011

Several notifications and alerts have been received by the Rapid Alert System for Food and Feed concerning food contact materials imported into the Union from the People's Republic of China and Hong Kong Special Administrative Region of the People's Republic of China, releasing into food or food simulant amounts of chemicals that are not in compliance with the Union legislation. Article 48(2) of Regulation (EC) No 882/2004 provides for the possibility to impose specific import conditions on particular products coming from certain third countries, taking into account the risks associated with these products. This Regulation applies from 1 July 2011. The provisions of this Regulation should be periodically reviewed, taking into account the information received from the Member States.

Products Covered: Kitchenware of polyamide and of melamine consigned from China or Hong Kong, China (TARIC Code 3924.10.00.11); ICS Code: 97.190.

Regulation Type: Regular notification

Distribution date: 06 July 2011

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc. has filed a petition proposing that the color additive regulations be amended to provide for the safe us of 1,4-bis[2-hydroxyethyl]amino]-9, 10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additive is intended to be copolymerized with various monomers for use as colored contact lens materials. ; ; (Please comment to Docket No. FDA-2011-C-0463) ;

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Regular notification

Distribution date: 06 July 2011

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc. has filed a petition proposing that the color additive regulations be amended to provide for the safe us of 1,4-bis[2-hydroxyethyl]amino]-9, 10-anthracenedione bis(2-methyl-2-propenoic)ester (C.I. Reactive Blue 247). The color additive is intended to be copolymerized with various monomers for use as colored contact lens materials. ; ; (Please comment to Docket No. FDA-2011-C-0463) ;

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Regular notification

Distribution date: 06 July 2011

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl) phenlyamino]anthraquinone (C.I. Reactive Blue 246). The color additive is intended to be copolymerized with various monomers for use as a colored contact lens material. ; (Please comment to Docket No. FDA-2011-C-0344.) ;

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Regular notification

Distribution date: 06 July 2011

The Food and Drug Administration (FDA) is announcing that CooperVision, Inc., has filed a petition proposing that the color additive regulations be amended to provide for the safe use of 1,4-bis[4-(2-methacryloxyethyl) phenlyamino]anthraquinone (C.I. Reactive Blue 246). The color additive is intended to be copolymerized with various monomers for use as a colored contact lens material. ; (Please comment to Docket No. FDA-2011-C-0344.) ;

Products Covered: Contact lenses (Color Additives) (HS 9001.30; ICS 11.120, 71.100)

Regulation Type: Regular notification

Distribution date: 29 June 2011 | Final date for Comment: 28 August 2011

The Food and Drug Administration (FDA) proposes to amend the ; sterility test requirements for biological products. This proposed rule ; is intended to provide manufacturers of biological products greater ; flexibility and to encourage use of the most appropriate and state-of- ; the-art test methods for assuring the safety of biological products. We ; are taking this action as part of our continuing effort to review and, ; as necessary, update the biologics regulations. ;

Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)

Regulation Type: Regular notification

Distribution date: 29 June 2011 | Final date for Comment: 28 August 2011

The Food and Drug Administration (FDA) proposes to amend the ; sterility test requirements for biological products. This proposed rule ; is intended to provide manufacturers of biological products greater ; flexibility and to encourage use of the most appropriate and state-of- ; the-art test methods for assuring the safety of biological products. We ; are taking this action as part of our continuing effort to review and, ; as necessary, update the biologics regulations. ;

Products Covered: Biological products (HS 3002, 3003, 3004, ICS 11.080, 11.100, 11.120)

Regulation Type: Regular notification

Distribution date: 29 June 2011

Products Covered: Lip make-up preparations (HS code(s): 330410); Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), incl. sunscreen or sun tan preparations (excl. medicaments, lip and eye make-up preparations, manicure or pedicure preparations and make-up or skin care powders, incl. baby powders) (HS code(s): 330499)

Regulation Type: Revision to Regular Notification