FSA Consultation Letter, 8 November 2006
This working document has been produced for discussion at the European Commission's working group on materials and articles in contact with food. The document could go on to form the basis of a fourth amendment to EC Directive 2002/72/EC. Responses are requested by: 14 December 2005
The version of the document attached [available on the FSA web site at: http://www.food.gov.uk/multimedia/pdfs/emb1105rev3.pdf ] is one in which changes have been added that resulted from the working group meeting two weeks ago. These are shown in italics. Therefore, please ignore numbering and grammatical errors and other editorial matters, your comments should concentrate on the principles being expressed in the document.
The Commission's working group is next due to meet in December to discuss this working document again, possibly over the period 19 to 21 December 2005. Any comments that you would like the Agency to consider by way of informing the United Kingdom negotiating line before that meeting should therefore be sent to Rusty Odihiri by Wednesday 14 December 2005 .
The process that this working document must go through before it can be adopted into EU harmonised law still has more stages to pass through, including the formal Commitology process of the Standing Committee on the Food Chain and Animal Health.
The European Commission is unlikely to clear this document through its internal process and adopt it as a formal proposal to the Standing Committee until sometime in the new year. It therefore remains possible to seek to affect the text even at that late stage and comments on the working document may therefore continue to be sent until 24 January 2006 . However, it is easier to effect change at earlier stages of the process and the sooner the Agency can consider comments, the better.
Introduction – EU-harmonised rules on food contact plastics
EC Directive 2002/72/EC is a specific measure on food contact plastic materials and articles as provided for by Regulation (EC) number 1935/2004. It lays down the rules governing the manufacture and placing on the market of these plastic materials and articles in order to promote the Single Market by providing one harmonised set of rules for businesses. It also ensures a high degree of protection for people's health from substances that might adventitiously migrate from those plastic materials and articles into the food with which they come into contact.
The directive does this by laying down rules on the substances that may be used in manufacturing plastic materials and articles, including restrictions on the use of particular substances. It also governs the labelling and provision of other information that should be given to the consumer or the food industry for the correct use of these materials and articles. The lists of substances that may be used in the manufacturing process and that contain the restrictions on their use fall into two main categories:
The effect of these lists is that only those substances that are in the first list may be used as starting substances and any plastic material additives that are used, but that are not in the second list must comply with Article 3 of Regulation (EC) number 1935/2004. In time this incomplete list of additives will be transformed into a positive list.
The working document – an overview
The working document contains the detail for possibly amending Directive 2002/72/EC in two ways. Firstly, it could routinely amend the lists of substances and the restrictions on their use in line with the published opinions of the European Food Safety Authority (EFSA). EFSA's role is to assess and advise on the risk that might arise to human health from ingestion of substances that could migrate adventitiously into food from the food contact plastic.
The European Commission, with the EU Member States, then considers EFSA's opinions before arriving at decisions on how to best manage any risk to human health that EFSA has identified. It is the outcome of this process that provides this routine revision to the lists of substances and restrictions on their use.
Secondly, the working document contains text that could amplify and clarify the existing provisions and it is this that provides the greatest area for discussion and comment. Among the ideas within the text that is to be discussed in December are those that would:
The working document in detail
The idea behind the text on the use of biocides in food contact plastics is included in the working document because manufacturers have sought permission to incorporate biocides into their food contact plastics to improve hygiene. The intention would not be to have a biocide in the material that migrates onto the food to kill bacteria. Instead, it would be locked into the polymer of the material to act on its surface, for example by preventing bacterial growth from food particles that may become trapped in the microscopic fissures of the material's surface.
The biocides permitted for use would only be those shown to be efficacious and on which EFSA has carried out a risk assessment and, subsequently, that have been incorporated into a positive list of biocides permitted for use in food contact plastics. Their use in manufacturing would only be permitted in compliance with any conditions on their use that are specified in the list. The materials and articles that may incorporate biocides would only be used for industrial application unless specific authorisation is given for their use elsewhere. Materials and articles containing a biocide would have to be identified as such by a label that would also contain instructions for their safe and appropriate use when they are placed on the market.
The labelling would have to comply with the general rules on labelling contained in EC Directive 2000/13/EC and neither the label nor the instructions for use would be allowed to mislead the consumer.
In excluding for now the need to carry out risk assessments on polymerisation production aids (PPAs), the text tries to deal with the problem of prioritising the substances that EFSA will have to assess for risk in the next couple of years. The impending problem of a build-up of substances requiring assessment by EFSA that will arise from the conversion of the present open lists of plastics additives to a positive list could become unmanageable without that prioritisation.
The text therefore recognises that while other additives remain in the finished material or article with the potential to migrate into food, PPAs are not meant to remain and should not therefore present the same migration problems. The text in the working document would therefore create a list of PPAs that is separate from the list of other plastics additives. In doing so it would enable only those PPAs listed to continue to be used while allowing the more necessary work to evaluate substances with the greater migration potential to be given priority.
The text seeks to correct the way the migration of substances into fatty foods is assessed by introducing the use of a Fat (consumption) Reduction Factor. This incorporates a more realistic figure for the amount of fatty food a person is likely to consume in a day. The conventional assumption in assessing the risk that may arise for people consuming food into which a substance has migrated is to say that a person will consume 1 kilogram of that packaged food per day. This amount has also so far been applied to calculations for chemical migration into fatty foods.
The text included in the working document recognises that this is an overestimation of the amount of fatty food a person would actually eat daily. The figure of 200 grams has therefore been taken from the EFSA opinion of 5 October 2004 related to the use of a Fat (consumption) Reduction Factor for infants and children. As a result, specific migration figures for lipophilic substances could be corrected by using a divisor of five in recognition of this lower amount of fatty food consumption.
It has long been enshrined in the legislation that businesses dealing with specific materials and articles in contact with food shall require a declaration of legal compliance about products. In accordance with Regulation (EC) number 1935/2004 the text in the working document now attempts to clarify how that should be done. It sets out that compliance shall be measured by specific migration limits and that, at the marketing stage, but not at the point of retail sale, the food contact plastic shall be accompanied by a written declaration. That declaration would have to provide adequate and relevant information at each stage of the supply chain to help ensure that the product is used suitably and safely.
The declaration would have to be reviewed regularly and whenever necessary. In the latter case this is likely to arise whenever there is a change to the make-up or conditions of manufacture or use of the product. The text also clarifies the information that would have to be contained in the declaration that accompanies the final product. This information would include the identities of the EU manufacturer or importer, the product and the plastic material/article; the date the declaration is made; confirmation of compliance with the EU regulation and any appropriate national laws on the conditions of use of the product (this would require quoting the specific legal references); adequate information about all substances used in the product for which there is a specific restriction on use; and, conditions about the correct use of the product. Additional information would have to be provided about the product's legal compliance where biocides had been used in the manufacture of the product.
In support of the declaration, the declaring business would have to maintain documentation that demonstrated compliance and this would include such compliance declarations as had been provided by upstream suppliers, the results of product testing, calculations and other internationally recognised methods that had been used to demonstrate compliance. The text here is not new. It is taken from text that had previously been discussed at length and largely agreed in the context of another working document that sought to consolidate and modernise all the existing EC Directives on food contact plastics.
Another text included in this document but which is taken from that other working document concerns multi-layer plastic materials and the use of so-called ‘functional barriers'. Current EU legislation lays down the rules for food contact materials and articles made of one or more layers of plastic bound together by some means. The rules currently require that each layer of a multi-layer plastic material is manufactured only from substances listed on EU-harmonised, or ‘Community' lists, or, in the case of plastics additives, substances listed on purely national lists within an EU Member State. The text of the working document does not affect these rules in relation to the plastic layer in contact with food. However, it envisages the use of a functional barrier as a means of allowing manufacturers greater freedom in the substances they could use to manufacture plastic layers behind the food contact layer.
The text inherently therefore recognises that better technical performance characteristics of the final material or article could be achieved if substances not listed for use could in fact be used in manufacturing the non-food contact layers of the plastic material. Although the improved performance characteristics could do more to ensure safer food, the text recognises that the use of unlisted substances could have undesirable consequences. Their use could have the potential to bring about products that could contain potential migrant substances that could be harmful to health and, in permitting this more liberal use of substances, that extra safety precautions would need to be taken. The text therefore envisages the use of a layer that has the property to protect the food from such migration by creating a barrier through which these substances would not pass. Once again, this text had previously been discussed at length and largely agreed in the context of that other working document.