FSA Consultation Letter, FSA Consultation Letter, 13 November 2006
For a copy of the conultation document see: Draft Food Supplements (England) (Amendment) Regulations 2007
The Agency seeks views and comments on the draft Food Supplements (England) (Amendment) Regulations 2007, which will implement Commission Directive 2006/37/EC in England . Comments are also sought on the Regulatory Impact Assessment. Responses are requested by: 8 January 2007
Consultation details
Key proposals for the amendment regulations
Detail of Consultation
These draft Regulations will amend The Food Supplements ( England ) Regulations 2003, SI 2003 1387. They are intended to implement, in England , Directive 2006/37/EC of 30 March 2006, which amended Directive 2002/46/EC relating to food supplements by adding two new substances to the positive lists in the Annexes. Parallel implementing legislation will be made in Scotland , Wales and Northern Ireland .
Directive 2002/46/EC lays down certain requirements relating to food supplements. Positive lists of permitted vitamins and minerals are included in the Annexes to the Directive. It also specifies the forms and units of measurement that may be used in food supplements and the labelling, presentation and advertising allowable and provides scope for future amendments to establish maximum and minimum levels of nutrients used in food supplements.
The purpose of the amendment Directive 2006/37/EC, which is being implemented by the draft regulations, is to add to the positive list those substances that have now been evaluated by EFSA and have received a positive opinion. In addition, it makes an amendment to one of the headings in the Annexes. Member States are required to implement these changes into their legislation by 30 April 2007. It is anticipated that these Regulations will come into force in the UK on 6 April 2007.
Derogation from the requirement for vitamin and mineral substances to be listed in the Annexes to the Directive has been allowed in the UK , where safety dossiers were submitted for assessment by EFSA not later than 12 July 2005. Derogation may apply until the end of 2009, if EFSA have not given an unfavourable opinion in respect of the use of that substance in food supplements. The substances to be added to the positive list of permitted sources of vitamins and minerals are on the UK derogation list and are, therefore, already permitted on the UK market.
The Agency seeks views and comments on the draft Food Supplements (England) (Amendment) Regulations 2007, which will implement Commission Directive 2006/37/EC in England . Comments are also sought on the Regulatory Impact Assessment. Responses are requested by: 8 January 2007
Consultation details
Key proposals for the amendment regulations
Detail of Consultation
These draft Regulations will amend The Food Supplements (England) Regulations 2003, SI 2003 1387. They are intended to implement, in England, Directive 2006/37/EC of 30 March 2006, which amended Directive 2002/46/EC relating to food supplements by adding two new substances to the positive lists in the Annexes. Parallel implementing legislation will be made in Scotland , Wales and Northern Ireland .
Directive 2002/46/EC lays down certain requirements relating to food supplements. Positive lists of permitted vitamins and minerals are included in the Annexes to the Directive. It also specifies the forms and units of measurement that may be used in food supplements and the labelling, presentation and advertising allowable and provides scope for future amendments to establish maximum and minimum levels of nutrients used in food supplements.
The purpose of the amendment Directive 2006/37/EC, which is being implemented by the draft regulations, is to add to the positive list those substances that have now been evaluated by EFSA and have received a positive opinion. In addition, it makes an amendment to one of the headings in the Annexes. Member States are required to implement these changes into their legislation by 30 April 2007. It is anticipated that these Regulations will come into force in the UK on 6 April 2007.
Derogation from the requirement for vitamin and mineral substances to be listed in the Annexes to the Directive has been allowed in the UK , where safety dossiers were submitted for assessment by EFSA not later than 12 July 2005. Derogation may apply until the end of 2009, if EFSA have not given an unfavourable opinion in respect of the use of that substance in food supplements. The substances to be added to the positive list of permitted sources of vitamins and minerals are on the UK derogation list and are, therefore, already permitted on the UK market.