Commission Directive
2007/19/EC
of
2 April 2007
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of
27 October 2004
on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
, and in particular Article 5(2) thereof,
After consulting the European Food Safety Authority (the Authority),
Whereas:
(1)
Commission Directive 2002/72/EC
is a specific Directive within the meaning of the framework Regulation (EC) No 1935/2004, harmonising the rules for the plastics materials and articles intended to come into contact with food.
(2)
Directive 2002/72/EC establishes a list of authorised substances for the manufacture of those materials and articles, in particular additives and monomers, the restrictions on their use, rules on labelling as well as the information to be given to consumers or to food business operators concerning correct use of those materials and articles.
(3)
Information provided to the Commission demonstrates that the plasticizers used e.g. in polyvinyl chloride (PVC) gaskets in lids may migrate into fatty foods in quantities that could endanger human health or bring about an unacceptable change in the composition of the foods. It should therefore be made clear that, even if they are part of e.g. metal lids, gaskets fall under the scope of Directive 2002/72/EC. At the same time, specific rules should be laid down as regard the use of additives for the manufacture of those gaskets. It is appropriate to take account of the need of lid manufacturers to have sufficient time to adapt to some of the provisions of Directive 2002/72/EC. In particular, taking into account the time needed to prepare an application for the evaluation of specific additives used for the manufacture of gaskets of lids, it is not yet possible to establish a timetable for their evaluation. Therefore, in a first stage, the positive list of authorised additives that will be adopted in the future for plastic materials and articles should not apply for the manufacture of gaskets in lids, so that the use of other additives will remain possible, subject to national law. This situation should be reassessed at a later stage.
(4)
On the basis of new information related to the risk assessment of substances evaluated by the Authority and the need to adapt to technical progress the existing rules for calculating migration, Directive 2002/72/EC should be updated. For reasons of clarity definitions of technical terms used should be introduced.
(5)
The rules for overall migration and specific migration should be based on the same principle and should therefore, be aligned.
(6)
Specific rules should be introduced to improve the protection of infants, since infants ingest more food in proportion to their body weight than adults.
(7)
The verification of compliance with the specific migration limits (SML) in simulant D for additives listed in Annex III, Section B, to Directive 2002/72/EC should be applied at the same time as the other provisions for calculating migration introduced in this Directive for better estimation of the real exposure of the consumer to those additives. Therefore, the deadline for application of the abovementioned verification of compliance should be extended.
(8)
The status of additives acting as polymerisation production aids (PPA) should be clarified. The PPA which also function as additives are to be evaluated and included in the future positive list of additives. Some of them are already included in the current incomplete list of additives. As regards additives which exclusively act as PPA and are therefore not intended to remain in the finished article, it should be made clear that their use will remain possible, subject to national law, even after the adoption of the future positive list of additives. That situation should be reassessed at a later stage.
(9)
Studies have shown that azodicarbonamide decomposes into semicarbazide during high temperature processing. In 2003 the Authority was asked to gather data and to assess the possible risks posed by semicarbazide in food. Until that information was obtained and in accordance to Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of
28 January 2002
laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
, the use of azodicarbonamide in plastic materials and articles was suspended by Commission Directive 2004/1/EC
. In its opinion of
21 June 2005
, the Authority
concluded that carcinogenicity of semicarbazide is not of concern for human health at the concentrations encountered in food, if the source of semicarbazide related to azodicarbonamide is eliminated. Therefore it is appropriate to maintain the prohibition of use of azodicarbonamide in plastic materials and article.
(10)
The concept of the plastic functional barrier, that is a barrier within plastic materials or articles preventing or reducing the migration from behind this barrier into the food should be introduced. Only glass and some metals may ensure complete blockage of migration. Plastics may be partial functional barriers with properties and effectiveness to be assessed and may help reducing the migration of a substance below a SML or a limit of detection. Behind a plastic functional barrier, non-authorised substances may be used, provided they fulfil certain criteria and their migration remains below a given detection limit. Taking into account foods for infants and other particularly susceptible persons as well as the difficulties of this type of analysis affected by a large analytical tolerance, a maximum level of 0,01 mg/kg in food or a food simulant should be established for the migration of a non-authorised substance through a plastic functional barrier.
(11)
Article 9 of Directive 2002/72/EC provides that materials and articles must be accompanied by a written declaration of compliance attesting that they comply with the rules applicable to them. In accordance with Article 5(1)(h) and (i) of Regulation (EC) No 1935/2004, to strengthen the co-ordination and responsibility of the suppliers at each stage of manufacture, including that of the starting substances, the responsible persons should document the compliance with the relevant rules in a declaration of compliance which is made available to his customer. Further, at each stage of manufacture, supporting documentation, substantiating the declaration of compliance, should be kept available for the enforcement authorities.
(12)
Article 17(1) of Regulation (EC) No 178/2002 requires the food business operator to verify that foods are compliant with the rules applicable to them. To this end subject to the requirement of confidentiality, food business operators should be given access to the relevant information to enable them to ensure that the migration from the materials and articles to food complies with the specifications and restrictions laid down in food legislation.
(13)
Compliance with Article 3 of Regulation (EC) No 1935/2004 for substances non-listed in Annexes II and III of Directive 2002/72/EC such as impurities or reaction products referred to in point 3 of Annex II and point 3 of Annex III to Directive 2002/72/EC should be assessed by the relevant business operator in accordance with internationally recognised scientific principles.
(14)
For a more adequate estimation of exposure of the consumer, a new reduction factor should be introduced in migration testing, called Fat Reduction Factor (FRF). Until now, the exposure to substances migrating predominantly into fatty food (lipophilic substances) was based on the general assumption that a person ingests daily 1 kg of food. However, a person ingests at most 200 g of fat on a daily basis. This should be taken into consideration through the correction of the specific migration by the FRF applicable to lipophilic substances in accordance with the opinion of the Scientific Committee on Food (SCF)
and the opinion of the Authority
.
(15)
On the basis of new information related to the risk assessment of monomers and other starting substances evaluated by the Authority
, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of authorised substances. For others, the restrictions and/or specifications already established at Community level should be amended on the basis of the new information available.
(16)
The incomplete list of additives which may be used in the manufacture of plastic materials and articles should be amended so as to include other additives evaluated by the Authority. For certain additives, the restrictions and/or specifications already established at Community level should be amended on the basis of those new evaluations available.
(17)
Commission Directive 2005/79/EC
introduced the changes in the restrictions and/or specifications for substance Ref. No 35760 in section A instead of section B of Annex III to Directive 2002/72/EC and for substance Ref. No 67180 the changes were introduced in section B instead of section A of that Annex. In addition, for substances Ref. No 43480, 45200, 81760 and 88640 the indication to the restrictions and/or specifications in Annex III to Directive 2002/72/EC is ambiguous. Therefore, for legal certainty, there is a need to place substances Ref. No 35760 and 67180 in the appropriate section of the list of additives and re-introduce the restrictions and specifications for substances Ref. No 43480, 45200, 81760 and 88640.
(18)
It has been shown that distilled water, which is used at present is not an adequate simulant for some milk products. It should be replaced by 50 % ethanol, which better simulates their fatty character.
(19)
Epoxidised soybean oil (ESBO) is used as plasticizer in gaskets. Taking into account the opinion of the Authority adopted on
16 March 2006
concerning exposure of adults to ESBO used in food contact materials, it is appropriate to set a shorter deadline for the compliance of gaskets of lids with the restrictions of ESBO and its substitutes set out in Directive 2002/72/EC. The same deadline should apply as regards the prohibition of use of azodicarbonamide.
(20)
Certain phthalates are used as plasticizers in gaskets and in other plastic applications. In its opinions on certain phthalates
published in September 2005 the Authority set tolerable daily intakes (TDI) for certain phthalates and estimated that the exposure of humans to certain phthalates is in the same range as the TDI. Therefore, it is appropriate to set a shorter deadline for the compliance of plastic materials and articles with the restrictions set in Directive 2002/72/EC for those substances.
(21)
Council Directive 85/572/EEC
and Directive 2002/72/EC should therefore be amended accordingly.
(22)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
OJ L 338, 13.11.2004, p. 4 .
OJ L 220, 15.8.2002, p. 18
. Directive as last amended by Directive 2005/79/EC (
OJ L 302, 19.11.2005, p. 35
).
OJ L 31, 1.2.2002, p. 1
. Regulation as last amended by Commission Regulation (EC) No 575/2006 (
OJ L 100, 8.4.2006, p. 3
).
OJ L 7, 13.1.2004, p. 45 .
The EFSA Journal (2005) 219, 1-36.
SCF opinion of
4 December 2002
on the introduction of a Fat (Consumption) Reduction Factor (FRF) in the estimation of the exposure to a migrant from food contact materials.
http://ec.europa.eu/food/fs/sc/scf/out149_en.pdf
Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food (AFC) on a request from the Commission related to the introduction of a Fat (consumption) Reduction Factor for infants and children, The EFSA Journal (2004) 103, 1-8.
The EFSA Journal (2005) 218, 1-9.
The EFSA Journal (2005) 248, 1-16.
The EFSA Journal (2005) 273, 1-26.
The EFSA Journal (2006) 316 to 318, 1-10.
The EFSA Journal (2006) 395 to 401, 1-21.
OJ L 302, 19.11.2005, p. 35 .
The EFSA Journal (2006) 332, 1-9.
The EFSA Journal (2005) 244, 1-18.
The EFSA Journal (2005) 245, 1-14.
The EFSA Journal (2005) 243, 1-20.
The EFSA Journal (2005) 242, 1-17.
The EFSA Journal (2005) 241, 1-14.
OJ L 372, 31.12.1985, p. 14 .
Substituted by Corrigendum to Commission Directive 2007/19/EC of 30 March 2007 amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food and Council Directive 85/572/EEC laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs (Official Journal of the European Union L 91 of 31 March 2007).