FSA Consultation Letter, 3 September 2008
A copy of the consultation document (including Appendices) is available on this site. See: Plactic Regulations Consultation
The proposed Plastic Materials and Articles in Contact with Food (England) Regulations 2009 will implement Commission Directive 2008/39/EC on plastic materials and articles intended to come into contact with food in english law. Responses are requested by: 28 November 2008
Detail of Consultation
We welcome your comments on the proposed Plastic Materials and Articles in Contact with Food (England) regulation 2009 [see Annex A in the link]. The proposed Regulation will implement the requirements of Commission Directive 2008/39/EC, amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food ('the new Directive'). Comments are also requested on the Impact Assessment [see Annex B]. In the latter case, we particularly welcome comment on any cost implications that may arise from this proposal. The new Directive was published in the Official Journal of the European Union on 7 March 2008 (OJ Ref. L63, 07.03.2008 p6-13). A copy of this Directive is also provided [see Annex C]. The Food Standards Agency in Scotland, Wales and Northern Ireland will consult on parallel but separate Regulations.
Comments are also requested on the draft guidance notes (see Annex H – see also section 12), that will accompany the proposed Regulations. When submitting comments, please indicate whether you are commenting on the guidance or the draft Regulation.
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 and as the harmonisation of the rules across the EU is extended. The Plastic Materials and Articles in Contact with Food (England) Regulations 2008 currently implement in England the provisions of Directive 2002/72/EC, as last amended by Directive 2007/19/EC as read with Commission Regulation (EC) No. 597/2008.
Commission Directive 2008/39/EC relating to plastic materials and articles intended to come into contact with food
The new Directive amends Commission Directive 2002/72/EC on plastic materials and articles intended to come into contact with food for the fifth time. The new Directive lays down the dates by which the list of additives used in manufacturing food contact plastics will be closed and makes interim arrangements for those additives for which an application for authorisation had been submitted by the deadline of December 2006. The Directive sets a date of 31 December 2009 up to which additives not on the positive list or the provisional list may continue to be used after that date. Any additives not on those lists are non-compliant with the Directive, which then specifies a short phase-out period ending on 7 March 2010 for plastic materials and articles manufactured or imported into the EU, which do not comply with Directive 2002/72/EC as amended by Directive 2008/39/EC. This period until December 2009 will enable the European Food Safety Authority (EFSA) to obtain any additional information it might need for its risk assessment of those additives on the provisional list. The Directive also routinely updates the lists of authorised substances, taking into account the published opinions of EFSA.
The new Directive required that the European Commission publish its provisional list of those additives that are the subject of an application for authorisation by 11 April 2008 and that the list will be kept up-to-date. That list has been published and is available on the Commission's website and can be accessed at: ec.europa.eu/food/food/chemicalsafety/foodcontact
An additive will be removed from the provisional list either when it is included in the positive list, or when a decision is taken not to include it in the positive list, or if additional information asked for by EFSA is not provided.
To avoid many amendments to our regulations and to make it easier for anyone needing to refer to them, we propose to follow our established practice of implementing the requirements of this amending Directive and its parent Commission Directive, 2002/72/EC and the various Council Directives laying down requirements for migration testing in one complete set of Regulations, namely The Plastic Materials and Articles in Contact with Food (England) Regulations 2009. To meet the requirements of the new Directive these Regulations have to be in force by 7 March 2009.
Who will be affected by the new regulations
The primary business sectors affected by these proposals will be those that manufacture, use, import or sell plastic food packaging and other plastic materials and articles intended for food contact.
Local enforcement authorities and businesses will benefit from the greater clarity of having the relevant rules and powers contained in one consolidated document. Charities and voluntary organisations are unaffected by this proposal.
Proposed timetable for the new regulations