In the “Food contact materials. Regulation (EC) 1935/2004 and (EC) 2023/2006” post these regulations were covered in detail, in other words, was explained the header of the regulatory frame of food contact materials. In this post we will expose the measures and specific rules that covers some of the materials and articles that appear in the Annex I of Regulation (EC) 1935/2004.
In the chart it can be observed that those pink colored boxes are applied to materials (active and intelligent materials and articles, ceramics, recycled plastics, plastics and regenerated cellulose). Green colored boxes are applied to specific substances (epoxy derivatives and nitrosamines) because of the migration of these substances to the foodstuff may be harmful for the consumer health. Regulations or Directives have been drafted to limit their use to levels which do not present any risk.
Down below, the rules on the chart are explained, excepting the Regulation (EC) 10/2011 which, due to its extension and complexity, we prefer to dedicate an exclusive post on it. Make yourself a cup of coffee and let’s start!
It lays down requirements on composition and includes restrictions concerning labelling, declaration of compliance and supporting documentation. As describes article 5 of this regulation, only the substances included in the “Community list” of authorized substances may be used in components of active and intelligent materials and articles. In respect of labelling restrictions, non-edible parts shall be marked with the words “DO NOT EAT” and, in addition, the symbol of annex I must figure in the material or article always when technically possible.
The Directive (modified by Directive 2005/31/EC regarding to the declaration of compliance and to the performance criteria of the analytical method) dictates maximum limits for lead and cadmium transferred from ceramic articles to the foodstuffs with which they enter into contact. The manufacturer or the importer must issue a written declaration guaranteeing that the ceramic articles comply with the stablished limits fpr lead and cadmium. This declaration, in accordance with article 16 of Regulation (EC) 1935/2004, shall contain the information laid down in Annex III to the Directive. The methods of analysis for determination of the migration of lead and cadmium are described in the annex II of the Directive 2005/31/EC.
It establishes that these materials and articles shall only be placed on the market if they contain recycled plastic obtained from an authorized recycling process. To obtain an authorized recycling process, the conditions listed on article 4 shall be complied, among which figures that both the quality of plastic input and the quality of the recycled plastic must be characterized and controlled. Where the authorization has been granted, it will contain all the aspects on point 3 of the article 6 of this Regulation, where conditions and requirements that shall be complied in the recycling process can be found. The control that these obligations are fulfilled will be taken regarding the rules exposed in the Regulation (EC) 882/2004.
It is applied to the materials and articles that applies Regulation (EC) 1935/2004 which are manufactures with or contain BADGE, BFDGE and NOGE, affecting mostly the varnishes and coatings of metal containers. Directive 2002/16/EC banned the use of BFDGE and NOGE from 2004 and the use of BADGE from 2005, waiting for new toxicological data. Only the results of BADGE have been reported and, as they did not raise concern about carcinogenicity and genotoxicity in vivo, the migration limits presented in Annex I of the Regulation have been established. BFDGE and NOGE substances are still prohibited.
It defines the regenerated cellulose film as a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. This Directive enumerated in Annex II a list of substances authorized in the manufacture of regenerated cellulose film. As stated in the Directive, the bis(2-hydroxyethyl)ether (= diethyleneglycol) and ethanediol (= monoethyleneglycol) can migrate extensively to certain foodstuffs. In order to avoid this migration, in the first part of Annex II, a maximum authorized quantity of these substance in foodstuffs which have been in contact with regenerated cellulose film is fixed.
It have been adopted because the teats and soothers may migrate N-nitrosamines and N-nitrosatable (capable to convert into N-nitrosamines). These substances can make a risk for the human health because of its toxicity and generate bigger concern when are used in the manufacture of articles widely used by babies and children. For this reason, the Directive fixes a maximum limit of 0,01 mg in total of N-nitrosamines released/kg (of the parts of teat or soother made of elastomer or rubber) and 0,1 mg in total of N-nitrosatable substances/kg (of the parts of teat or soother made of elastomer or rubber). The basic rules for determining the release of these substances and criteria applicable to the method for determining of its level are exposed in the annexes I and II of the Directive, respectively.
Any material or substance covered by one or more rules explained above, beside being in compliance with this or these rule or rules, also must comply the Regulation (EC) 1935/2004 and the Regulation (EC) 2023/2006 and, as we commented in some of the previous points, the material or substance must include a written declaration which demonstrated this compliance.
When you doubt of what applies to your products, which requirements or restrictions must be complied, if it is given the presence of new authorized substances to consider for a possible improvement of your product composition, if it has been published new dispositions that maybe you do not take into account in your declaration of compliance or any other doubt related to the legislative area, RepaQ team will be pleased to resolve your concerns. Contact us!