Legislation on Specific Materials

Legislation on Specific Materials

Below you can find guidance about ceramic articles, plastic materials, recycled plastic materials and articles, regenerated cellulose film, active and intelligent materials, materials containing certain epoxy derivatives.

• Ceramic Articles

  Council Directive 84/500/EEC of 15 October 1984 on the approximation of the laws of the Member States relating to ceramic articles intended to come into contact with foodstuffs (OJ L227, 20/10/1984),  as amended.

  Under Directive 84/500/EEC, as amended 'ceramic articles' are defined as "articles manufactured from a mixture of inorganic materials with a generally high argillaceous or silicate content to which small quantities of organic materials may have been added". These articles are first shaped and the shape obtained is permanently fixed by firing. They may be glazed, enamelled and/or decorated. The Directive is concerned with the possible migration of lead and cadmium from ceramic articles  and it sets limits for these compounds that must not be exceeded by ceramic articles which, in their finished state, are intended to come into contact with foodstuffs, or which are in contact with foodstuffs.

  The quantities of lead and cadmium transferred from ceramic articles is determined by means of a test, the conditions of which are specified in Annex I to the Directive using the method of analysis described in Annex II.

  At the marketing stages up to and including the retail stage, ceramic articles which are not yet in contact with foodstuffs must be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No. 1935/2004, as amended. That declaration must be issued by the manufacturer or by a seller established within the EU and must contain the information laid down in Annex III to Directive 84/500/EEC, as amended.

• Plastic Material and Articles

  Commission Regulation (EU) No. 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L012 15/1/2011), as amended is a specific measure within the meaning of Article 5(1) of Regulation (EC) No. 1935/2004, as amended.  It applies to materials and articles which are placed on the EU market and which fall under the following categories:

  (a) materials and articles and parts thereof consisting exclusively of plastics;
  (b) plastic multi-layer materials and articles held together by adhesives or by other means;
  (c) materials and articles referred to in points a) or b) that are printed and/or covered by a coating;
  (d) plastic layers or plastic coatings, forming gaskets in caps and closures, that together with those caps and closures compose a set of two or more layers of different types of materials;
  (e) plastic layers in multi-material multi-layer materials and articles.

  Plastic materials and articles may only be placed on the market if they:

  (a) comply with the relevant requirements set out in Article 3 of Regulation (EC) No. 1935/2004, as amended under intended and foreseeable use; and
  (b) comply with the labelling requirements set out in Article 15 of Regulation (EC) No. 1935/2004, as amended; and
  (c) comply with the traceability requirements set out in Article 17 of Regulation (EC) No. 1935/2004, as amended; and
  (d) are manufactured according to good manufacturing practice as set out in Commission Regulation (EC) No. 2023/2006, as amended; and
  (e) comply with the compositional and declaration requirements set out in Chapters II, III and IV of Regulation (EU) No. 10/2011, as amended.

  Substances used in the manufacture of plastic layers in plastic materials and articles must be of a technical quality and a purity suitable for the intended and foreseeable use of the materials or articles. The composition must be known to the manufacturer of the substance and made available to the competent authorities on request.

  Specific requirements on substances
  Substances used in the manufacture of plastic layers in plastic materials and articles must meet the following requirements and specifications as set out in Regulation (EU) No. 10/2011, as amended:

  (a) the specific migration limit set out in Article 11
  (b) the overall migration limit set out in Article 12
  (c) the restrictions and specifications set out in column 10 of Table 1 of point 1 of Annex I;
  (d) the detailed specifications set out in point 4 of Annex I

  Substances in nanoform must only be used if explicitly authorised and mentioned in the specifications in Annex I.

  Migration limits

  Plastic materials and articles must not transfer their constituents to foods in quantities exceeding the specific migration limits (SML) set out in Annex I to Regulation (EU) No. 10/2011, as amended. Those specific migration limits (SML) are expressed in mg of substance per kg of food or food simulant (mg/kg).

  A generic overall migration limit of 60 mg/kg applies to substances which have no SML or other restrictions provided in Annex I.

  Declaration of compliance

  At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC) No. 1935/2004, as amended must be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles. This written declaration must contain the information laid down in Annex IV. It must permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued. It must be renewed when substantial changes in the composition or production occur that bring about changes in the migration from the materials or articles or when new scientific data becomes available.

  Testing Migration of Plastic Materials

  Council Directive 82/711/EEC, as amended of 18 October 1982 laying down the basic rules necessary for the testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs (OJ L097, p26, 23/10/1982), as amended.

  Implementing measures

  Council Directive 85/572/EEC of 19 December 1985 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 (OJ L372, p14, 31/12/1985), as amended.

• Recycled plastic materials and articles

  Commission Regulation (EC) No. 282/2008  of 27 March 2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No. 2023/2006 (OJ L86, p9, 28/03/2008), as amended applies to plastic materials and articles and parts thereof intended to come into contact with foodstuffs as referred to in Regulation (EU) No. 10/2011 which contain recycled plastic. The plastic materials and articles that fall within the scope of Commission Regulation (EC) No. 282/2008, as amended also remain subject to the requirements of Regulation (EU) No. 10/2011, as amended.

  Commission Regulation (EC) No. 282/2008, as amended does not apply to the following recycled plastic materials and articles, provided that they have been manufactured according to good manufacturing practice, as laid down in Regulation (EC) No. 2023/2006, as amended:

  1. recycled plastic materials and articles made with monomers and starting substances, derived from chemical depolymerization of plastic materials and articles;

  2. recycled plastic materials and articles made from unused plastic production offcuts and/or process scraps in compliance with Regulation, that are recycled within the manufacturing site or are used at another site;

  3. recycled plastic materials and articles in which the recycled plastic is used behind a plastic functional barrier, as specified in Regulation (EU) No. 10/2011, as amended. Commission Regulation (EC) No. 282/2008, as amended lists the requirements for recycled plastic materials and articles to be used in FCMs as well as the conditions that a recycling processes must meet in order to be authorised. A safety assessment of the recycling process will be carried out by the European Food Safety Authority following the submission of an application for approval.

• Regenerated Cellulose Film

  Commission Directive 2007/42/EC of 29 June 2007 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs (OJ L 172, p71, 30/06/2007).
  
  Annex I of Commission Directive 2007/42/EC defines regenerated cellulose film as "a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides."

  Commission Directive 2007/42/EC applies to regenerated cellulose film that meets this definition, which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does come into such contact and which either:

  1. constitutes a finished product in itself; or
  2. forms part of a finished product containing other materials.

  The Directive does not apply to synthetic casings of regenerated cellulose.

  The rules to be applied to the regenerated cellulose films are specific to the nature of the layer in contact with the foodstuff. Accordingly, the requirements for regenerated cellulose films coated with coatings consisting of plastics are different from those provided for regenerated cellulose films uncoated or coated with coatings derived from cellulose. In the case of regenerated cellulose films coated with coatings consisting of plastics, the layer in contact with foodstuffs consists of a material similar to plastic materials and articles intended to come into contact with foodstuffs. Therefore the rules provided for in Regulation (EU) No. 10/2011, as amended relating to plastic materials and articles intended to come into contact with foodstuffs apply also to such films.

• Active and intelligent materials and articles

  Commission Regulation (EC) No. 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (OJ L 135, p3, 30/05/2009), as amended establishes specific requirements for the marketing of active and intelligent materials and articles intended to come into contact with food. It defines ‘active materials and articles’ as “materials and articles that are intended to extend the shelf-life or to maintain or improve the condition of packaged food; they are designed to deliberately incorporate components that would release or absorb substances into or from the packaged food or the environment surrounding the food”.

  ‘Intelligent materials and articles’ are defined as “materials and articles which monitor the condition of packaged food or the environment surrounding the food”.

  Declaration of compliance for active and intelligent materials 

  At the marketing stages other than at the point of sale to the final consumer, active and intelligent materials and articles, whether or not they are in contact with food, or the components intended for the manufacturing of those materials and articles or the substances intended for the manufacturing of those components, must be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No. 1935/2004, as amended. The declaration must be issued by the business operator and must contain the information set out in Annex II to Regulation (EC) No. 450/2009, as amended.

  Labelling of active and intelligent materials

  To allow consumers to identify the non-edible parts of these materials, operators are obliged to label parts that may be perceived as edible:

  (a) with the words ‘DO NOT EAT’; and
  (b) always where technically possible, with the symbol reproduced in Annex I to Regulation (EC) No. 450/2009, as amended

  This information must be conspicuous, clearly legible and indelible. It must be printed in characters of a font size of at least 3 mm and comply with the requirements set out in Article 15 of Regulation (EC) No. 1935/2004, as amended.

  Released active substance are considered as ingredients within the meaning of Article 2(f) of  Regulation (EU) No. 1169/2011 on the provision of food information to consumers (OJ L304, p18-63, 22/11/2011), as amended and are subject to the provisions of that Regulation.

• Materials Containing Certain Epoxy Derivatives

  Commission Regulation (EC) No. 1895/2005 of 18 November 2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food (OJ L30, p28, 19/11/2005 ).

  Regulation (EC) 1895/2005 applies to materials and articles, including active and intelligent FCMs and articles, as referred to in Article 1(2) of Regulation (EC) No. 1935/2004, as amended which are manufactured with or contain one or more of the following substances:

  1. 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether, (‘BADGE’ (CAS No 001675-54-3)), and some of its derivatives;
  2. bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers, (‘BFDGE’ (CAS No 039817-09-9));
  3. other novolac glycidyl ethers, hereinafter referred to as ‘NOGE’

  For the purposes of the Regulation, ‘materials and articles’ are:

  1. materials and articles made of any type of plastics
  2. materials and articles covered by surface coatings; and
  3. adhesives.

  This Regulation does not apply to containers or storage tanks having a capacity greater than 10,000 litres or to pipelines belonging to or connected with them, covered by special coatings called ‘heavy-duty coatings’.

  At the marketing stages other than the retail stages, materials and articles containing BADGE and its derivatives must be accompanied by a written declaration in accordance with Article 16 of Regulation (EC) No. 1935/2004, as amended. Appropriate documentation must be available to demonstrate such compliance and that documentation shall be made available to the competent authorities on demand.

  Annex 1 to the Regulation sets out the specific migration limit for BADGE and certain of its derivatives.