FSA Consultation Letter, 18 May 2006

ADDITIVES – Consultation on Draft regulations implementing EC Directive 2006/33/EC amending Directive 95/45/EC as regards Sunset Yellow FCF (E 110) and Titanium Dioxide (E 171)

The FSA are seeking views and comments on the enclosed draft Regulations that will amend the Colours in Food Regulations 1995 to implement Commission Directive 2006/33/EC in England . Responses are requested by: 11 August 2006

Consultation details

The key proposals are:

• The specification for Sunset Yellow FCF (E 110 ) has been amended to include a new limit for Sudan I of 0.5 mg/kg, as requested by the UK delegation at the European Commission's Food Additives Working Group meeting in Brussels on 21 November 2005 . Sudan I is an illegal colour and a genotoxic carcinogen, which may be formed under certain circumstances as an impurity during the production of Sunset Yellow
• The permitted level of lead in Sunset Yellow has been reduced from 10 mg/kg to 2 mg/kg in line with the FAO/WHO Joint Expert Committee on Food Additives (JECFA) specifications
• The specification for Titanium Dioxide (E 171) has been amended to permit the use of rutile titanium dioxide as well as the presently permitted anatase form, in line with the opinion of the European Food Safety Authority's Scientific Panel on Food Additives, adopted on 7 December 2004

Commission Directive 95/45/EC lays down specific purity criteria (specifications) for colours for use in foods throughout the European Union (EU). It has been amended on three previous occasions. It contains details of the specific purity criteria for colours permitted by European Parliament and Council Directive 94/36/EC on colours for use in foodstuffs.

Directive 2006/33/EC

Changes to the purity criteria for Sunset Yellow and Titanium Dioxide set out in Directive 2006/33/EC were agreed at a meeting of the European Commission's Standing Committee in Brussels on 16 December 2005 . Directive 2006/33/EC of 20 March 2006, which was published in the Official Journal of the European Communities (L 82/10 of 21 March 2006), amends Directive 95/45/EC for the fourth time.

The proposed regulations

The Colours in Food Regulations 1995 have been amended three times (in 2000, 2001 and 2005) to implement Commission Directives 1999/75/EC, 2001/50/EC and 2004/47/EC. The enclosed draft Colours in Food (Amendment) ( England ) Regulations 2006 will implement the provisions of Directive 2006/33/EC in England .

Member States are required to implement the provisions of Directive 2006/33/EC into national legislation by 10 April 2007 and to prohibit products that do not comply with the Directive by this date. We would like to implement the legislation as soon as possible in order to ensure the protection of human health and the interests of consumers (sunset yellow specification), whilst taking account of new scientific and technological developments in food additive usage (titanium dioxide specification). It is planned that the new regulations will come into force in England on the common commencement date of 1 October 2006 .

The following document is available on this site:

• Colours in Food (Amendment) ( England ) Regulations 2006: draft statutory instrument