FSA Consultation Letter, 2 July 2004
The Agency invites your comments on proposals to amend again the Plastic Materials and Articles in Contact with Food Regulations 1998 by transposing a new European Commission Directive into English law. Comments are also invited on an initial assessment of the impact of the proposed Regulations. Responses are requested by: 21 September 2004
The amending regulations being proposed, The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005, would implement a directive on plastic materials and articles intended to come into contact with food.
This directive, 2004/19/EC, amends Commission Directive 2002/72/EC, by amending lists of substances in that directives that may be used in the manufacture of food contact plastics and begins the process of creating a positive list of additives permitted for use in the manufacture of food contact plastics. The Directive was published in the Official Journal in March 2004 (OJ reference L71, 10.3.2004, pp7-21).
Reasons for changing the rules
Harmonised European rules on food contact plastics are laid down by Commission Directive 2002/72/EC. These rules are routinely amended as technical and scientific knowledge develops. The rules are implemented in Great Britain by The Plastic Materials and Articles in Contact with Food Regulations 1998 (SI 1998 No. 1376), as amended in England (by SIs 2000 No. 3162, 2002 No. 2364 and 2002 No. 2008). Similar amendments have been made to regulations to reflect these changes in Scotland, Wales and Northern Ireland. The new European amending Directive has therefore to be implemented by amending the regulations currently in place. The main elements of the proposals are summarised below.
Lists of substances
This latest amendment, arising from Commission Directive 2004/19/EC, makes routine amendments to the Community list of permitted monomers in Annex II to Directive 2002/72/EC and the incomplete list of additives in Annex III to that Directive. These amendments include new substances and amend the entries for others following the adoption of recommendations made the European Food Safety Authority. Regulations 8-16 of the proposed amending Regulations give effect to this change.
Date for closing the list of additives
The European Commission is required to nominate a date, 31 December 2007, for closing the list of additives used in the manufacture of food contact plastics, as the first step in creating a positive list of additives. The Commission shall establish by 31 December 2007 a provisional list of additives containing those that are, at 31 December 2006, already authorised in one or more EU Member States and for which the necessary data stipulated by the EFSA has been submitted. Regulation 5 of the proposed amending Regulations gives effect to this change.
Date for data submission on additives
In support of the establishment of a closed or positive list of additives the European Commission requires Member States to provide for the submission of the required data by 31 December 2006 to the EFSA for any additive that is to be entered on the provisional list. Regulation 5 of the proposed amending regulations gives effect to this change.
Use of Additives in Food Contact Plastics that are Authorised Food Additives
The new amending directive clarifies the relationship between Directive 2002/72/EC and directives on food additives and flavours, where substances may be used in food and plastic food contact materials.
Therefore the directive proposes that additives used in the manufacture of food contact plastics that are also authorised food additives shall not migrate into foodstuffs: in quantities having a technological function in the final foodstuffs; in excess of the amounts permitted by food additives rules; or, where they are not authorised as an additive in a particular food, in excess of the amount permitted by Directive 2002/72/EC, as amended.
Although the amendment permits national rules to be applied, pending the adoption of Community provisions, governing the use of additives in 'active' food contact materials, none have been adopted in the United Kingdom. Regulations 4 and 6 of the proposed amending Regulations give effect to this change.
It is proposed to implement the requirements of this Directive in one set of regulations that have to be in force by 1 September 2005.
Who will be affected by the new regulations?
Within the European Union, consumers should benefit from these regulations. The EU measure should have equal effect across the European Union, ensuring that UK consumers have the same health protection from excessive consumption of substances dealt with in these proposals, as consumers in the rest of the EU. The primary business sectors affected by these proposals will be manufacturers of food contact plastics. Charities and voluntary organisations are unaffected by this proposal. Local enforcement authorities will benefit from the greater clarity of the rules and with which their rights of access to information are spelled out.
Proposed timetable for new regulations
Important dates in the introduction of the new Regulations are: