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Materials in Contact with Food
Updating of information on the use of Bisphenol A in materials in contact with food
Bisphenol A (BPA or 2,2-bis-(4-hidroxyphenylpropane) is a chemical product that has been used for many years as a component in the manufacture of polycarbonate and epoxy-phenolic resins. Polycarbonate is a type of rigid, transparent plastic used to make food containers, such as returnable drinks bottles, baby's bottles, crockery (plates and cups) and containers. Epoxy-phenolic resins are used in coatings and linings for preserves and storage tanks for food and drinks.
Publication of Commission Regulation (EU) No 1282/2011, of 28 November 2011, amending Annex I of Regulation (EU) No 10/2011
On 10 December 2011, Commission Regulation (EU) No 1282/2011 of 28 November 2011 amending and correcting Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food was published in the Official Journal of the European Union.
Regulation of active and intelligent materials and objects intended to come into contact with food
Commission Regulation (EC) No 450/2009, published in the Official Journal of the European Union of 30 May 2009, lays down specific requirements for the sale of active and intelligent materials and articles intended to come into contact with food.
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, sets out some of the rules applying to active and intelligent materials and articles, but the final rules had to be set by a specific measure.
Publication of Royal Decree 1631/2011 amending Royal Decree 981/2006, of 21 July, approving the technical and sanitary regulations applicable to ceramic objects intended to come into contact with foodstuffs.
29/11/11
Ceramic objects are defined as the set of products derived from the transformation of clay in contact with water and at high temperature. The chemical composition has physical properties different to those making them finally suitable for use in the manufacture of a type of ceramic object. These objects include those intended to come into contact with foodstuffs, currently regulated in our legal system by Royal Decree 981/2006, which incorporates the Community legislation established under Directive 84/500/EEC.
From the food safety viewpoint, the migration of lead and cadmium resulting from the glazing of the clay, which serves to seal the article, must be taken into account. Hence the current legislation establishes the maximum accepted migration levels for these metals. To do so, Royal Decree 981/2006 has been adapted, eliminating the additional measures concerning the non-appearance of exudate, and drawing attention to the requirement to apply Commission Regulation (EC) No 2023/2006, of 22 December 2006, on good manufacturing practice for materials and articles intended to come into contact with food, which encourage the operator to set up quality management systems for their manufacturing processes which determine the need to control the correct application of enamel during the glazing phase.
Judgment of the General Court (Fourth Chamber) of Luxembourg of 19 March 2010 concerning the Commission Decision
concerning the non-inclusion of 2,4,4’-trichloro-2’-hydroxydiphenyl ether in the Union list of additives which may be used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs under Directive 2002/72/EC
03/11/11
On 25 October 2011, the General Court (Fourth Chamber) of Luxembourg ruled on case T 262/10.
This case refers to the action brought by the companies Microban International Ltd, established in Huntersville, North Carolina (United States) and Microban (Europe) Ltd, Cannock (United Kingdom) against the Commission Decision, of 19 March 2010, concerning the non-inclusion of 2,4,4’-trichloro-2’-hydroxyphenil ether in the Union list of additives which may be used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs under Directive 2002/72/EC, published in the OJEU on 23 March 2010.
The said Decision indicated the reasons for the non-inclusion of this substance in annex III of the Commission Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs, at the express wish of the manufacturer to withdraw the application in considering that its use in plastics intended to come into contact with foodstuffs was no more appropriate.
The Fourth Chamber of this Court ruled as follows: the Commission Decision of 19 March 2010 is ANNULED, thus the substance known as 2,4,4’-trichloro-2’-hydroxiphenyl ether shall be INCLUDED again in the provisional list of additives used in plastics.
Update of the evaluation by EFSA of the Recycling Processes of Plastic Materials Intended to Come into Contact with Foods.
21/07/2011
On 20 July 2011, the EFSA CEF Panel published the opinion: “Scientific Opinion on the criteria to be used for safety evaluation of a mechanical recycling process to produce recycled PET intended to be used for manufacture of materials and articles in contact with food”, which sets out the development of the specific criteria used during the evaluation process of this type of plastics.
The fundamental principle of the evaluation of the effectiveness of the recycling process is based, according to this new scientific opinion, in comparing the residual concentration of contaminants in recycled PET (Cres) following the implementation of the recycling process proposed by the petitioner, with a modelled concentration (Cmod).
The Panel considers that if a recycling process, after the application of the decontamination processes described thereto, is able to reduce initial contamination of 3mg/kg PET to a Cres < Cmod, the potential dietary exposure to substances present in PET cannot be higher than 0.0025 µg/kg bw/day, and migration, therefore, is below 0.1 µg/kg, so the recycling process is not considered of safety concern.
Finally, The Panel considered appropriate that the proportion of PET from non-food consumer applications should be no more than 5% in the input to be recycled.
In the event that these conditions could not be proved, the petitioner shall provide further information to prove the safety of the process.
Publication of Royal Decree RD 846/2011, passed in Spain on 17th June 2011
15/07/11
Publication of Royal Decree RD 846/2011, passed in Spain on 17th June 2011 establishing the conditions required for raw materials based on recycled polymeric materials for use in materials and articles intended to come into contact with food.
Publication of Royal Decree RD 847/2011, passed in Spain on 17th June 2011
15/07/11
Publication of Royal Decree RD 847/2011, passed in Spain on 17th June 2011 establishing a positive list of approved substances for the manufacture of polymeric materials intended to come into contact with food.
Publication of Commission Regulation (EU) No 284/2011 of 22 March 2011
23/03/11
The European Commission, in cooperation with Member States through the Committee of Experts on Materials coming into Contact with Food, has published the new Regulation (EU) No. 284/2011, laying down specific conditions and detailed procedures for the import of polyamide and melamine plastic kitchenware originating in or consigned from the People’s Republic of China and Hong Kong Special Administrative Region, China.
Publication of the Commission Regulation (EU) no. 10/2011 of 14th January on plastic materials and articles intended to come into contact with food
On 15th January 2011, Commission Regulation (EU) no. 10/2011 of 14th January 2011 on plastic materials and articles intended to come into contact with food was published in the OJEU, and it will be applicable as from 1st May 2011, except in special cases (amendment of food simulants, updating of migration tests, and so forth)
Publication of Regulation (EC) No 975/2009 on plastics
On 20 October last, Commission Regulation (EC) No 975/2009 of 19 October 2009, amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with foodstuffs, was published in the OJEU and was the sixth amendment to European rules on plastics.
The novelty is that this directive is not amended by another directive, but by a regulation, which means that it is directly implemented in Member States, and therefore, does not have to be transposed to national legislation.
Approval of this regulation arises from the need to update the approved list of monomers and other primary substances and additives included in Directive 2002/72/EC, once EFSA has pronounced itself in favour of these. The annexes included by the Regulation are those included in the Directive, which, transposed to Spain's Royal Decree 866/2008, 23 May, approving the list of substances permitted to manufacture materials and plastic articles intended to come into contact with food and regulating certain testing conditions, are the following:
Annex I of the Regulation: amends annex II of the Royal Decree.
- Annex II of the Regulation: amends annex III of the Royal Decree.
- Annex III of the Regulation: amends annex VI of the Royal Decree.
- Annex IV of the Regulation: amends annex V of the Royal Decree.
- Annex V of the Regulation: amends annexes II and III of the Royal Decree.
For further information, visit the AESAN web page.
Publication of the Guidance document to apply for assessment of active and intelligent substances present in articles and materials intended to come into contact with food
On 14 August 2009, EFSA (European Food Safety Authority) published the Guidance document for presenting applications for active and intelligent substances present in active and intelligent articles and materials intended to come into contact with food. From that date, and within 18 months, according to the provision of article 8.2 of Commission Regulation (EC) No 450/2009 of 29 May 2009, on active and intelligent materials and articles intended to come into contact with food, interested business operators must send their application to the Spanish Food Safety and Nutrition Agency, which will forward the documentation to EFSA.
End of the extension for implementing migration limits for plastifiers
Directive 2007/19/EC of the Commission, amending for the fourth time Directive 2202/72/EC concerning materials and objects intended to come into contact with food, transposed to Spanish legislation by Royal Decree 866/2008, 23 May 2008 lays down that, from 1 July 2008, Member States must prohibit the manufacture and import of lid seals that do not comply with provisions in the directive.
Provisional list of additives for the manufacture of plastics
Commission Directive 2008/39/EC, published in the Official Journal of the European Union on 7 March last, was the fifth modification to Directive 2002/72/EC on plastic materials and articles intended to come into contact with foods.
Coming into force of the Regulation on good practice in manufacturing materials and objects intended to come into contact with food
Next 1 August Regulation (EC) No 2023/2006 of the Commission of 22 December 2006, on good manufacturing practice for materials and articles intended to come into contact with food modified by Commission Regulation (EC) No 282/2008 of 27 March 2008, on recycled plastic materials and articles intended to come into contact with foods
Publication of the Guidance document to apply for assessment of recycling processes of plastics intended to come into contact with food
On 1 July 2008, EFSA (European Food Safety Authority) published the Guidance for presenting applications for recycling processes for plastics intended to come into contact with food. From that date, and within 18 months, according to the provision of article 13.2 of Regulation (EC) No 282/2008 of the Commission of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods amending Regulation (EC) No 2023/2006, interested business operators must send their application to the Spanish Food Safety and Nutrition Agency, which will forward the documentation to EFSA.
Updating Community Legislation on Plastics
Directive 2008/39/EC, of the Commission, published in the Official Journal of the European Union last Friday, 7 March, is the fifth modification to Directive 2002/72/EC, concerning plastic materials and objects intended to come into contact with food products.
Approval of the Regulation on recycled plastics in contact with food
Commission Regulation (EC) No 282/2008, published in the Official Journal of the European Union last 28 March, lays down the bases for the use of recycled plastics in containers intended to come into contact with food, in response to the need to use recycled materials, both from and economic and environmental point of view.
Instructions for presenting applications for assessing substances for manufacturing materials and objects intended to come into contact with food
Regulation 1935/2004 of the European Parliament and the Council, 27 October 2004, on materials and objects intended to come into contact with food, and which repeal Directives 80/590/EEC and 89/109/EEC, lays down the procedure to be followed for including new substances in the lists of authorised substances for the manufacture of these, and consists in presenting an application in any member state of the EU. The Spanish Agency for Food Safety has prepared a file with instructions, as a complement to those prepared by the European Food Safety Authority (EFSA), to facilitate the task of filling out applications to be presented in Spain.
Since 27 October 2006, materials in contact with food have to be traceable
From 27 October 2006, it has been compulsory to ensure the traceability of materials and objects intended for coming into contact with food, at all stages of manufacture, transformation and distribution, due to article 17 of Regulation 1935/2004 of the European Parliament and the Council, 27 October 2004, coming into force, on materials and objects intended to come into contact with food, and which repeal Directives 80/590/EEC and 89/109/EEC.
This fulfils demands for traceability stipulated in article 18 of Regulation 178/2002 of the European Parliament and the Council, 28 January 2002, laying down the principles and general requirements on food legislation, and creating the European Food Safety Authority and establishing procedures on food safety which came into force on 1 January 2005. These were intended to ensure the traceability, at all stages of production, transformation and distribution, of food, animal feed, animals for the production of food and of "any substance intended to be incorporated in a food or animal feed, or with a likelihood of this", in order to be able to track it.
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