Please Explain the Details Surrounding the French Positive List.
We manufacture several organic compounds that are blended with pigments to make colorants for use in food packaging. Are our products affected by the 'French Positive List'? Where can this list be found?
At the outset, we would like to highlight that there is currently no legally binding positive list applicable to colorants/pigments used in the manufacture of food packaging in France. We have set out some background information below as to the requirements applicable to organic compounds and pigments/colorants used in the manufacture of food packaging intended to be placed on the market in the EU, and why we consider that there is currently no legally binding positive list in France applicable to pigments/colorants used in the manufacture of food packaging.
If your company manufactures organic compounds which it supplies to a customer who subsequently manufactures colorants by adding pigments, then your company would have to ensure that its organic compounds comply with Article 3.1 of the EU’s Framework Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food, as amended, which states that:
- Materials and articles, including active and intelligent materials and articles, shall be manufactured in compliance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer their constituents to food in quantities which could:
- (a) endanger human health; or
- (b) bring about an unacceptable change in the composition of food; or
- (c) bring about a deterioration in the organoleptic characteristics thereof.
Likewise, if your company also adds the pigments to the organic compounds to make the colorants, and wishes to market these colorants in the EU for use in food contact applications, then the colorants should comply with Article 3.1 of the Framework Regulation. Thereafter, the colorants may be placed on the market in the EU subject to Member State legislation and the mutual recognition principle. In this regard, we would like to highlight that the Netherlands, Spain, Italy, Greece, the Czech Republic, Slovakia and Romania maintain legally binding purity requirements for colorants. The German Institute for Risk Assessment (‘the BfR’) has also issued a Recommendation on colorants used in the manufacture of plastic materials and articles (BfR Recommendation IX), which, although not legally binding, is often referred to in practice. Finally, again, although not legally binding, we would like to recall that the Council of Europe has issued a Resolution on colorants used in the manufacture of food-contact plastic materials or articles (Resolution AP (89) 1 on the use of colorants in plastic materials coming into contact with food), which may be useful in a safety assessment of such colorants.
As we noted earlier, there are currently no legally binding national provisions specifically applicable to pigments/colorants intended for use in food contact materials in France. By way of background, Circulaire No. 176 of 2 December 1959 on pigments and colorants intended for use in plastic materials and packaging was the reference text for assessing whether colorants used in plastic materials and articles complied with French food contact legislation. However, in December 2008, France published a decree (Decree no 2008-1281), which requires circulaires to be posted on a specific website by May 1, 2009, and if not, such circulaires may be deemed to be repealed. To date, Circulaire No 176 has not been included on the website. In addition, the Conseil d'Etat, the highest court in France for administrative matters, ruled that if a circulaire in place before May 1, 2009 was not posted to the specific website by that date, then it is deemed to be repealed even if the circulaire was placed on the website after May 1, 2009. That said, we note that the French competent authorities, the Directorate General for Competition Policy, Consumer Affairs and Fraud Control (DGCCRF), as recently as February 2015 (in its guidance note on printing inks, coatings and varnishes intended for printing on the outside of food contact materials), referred to Circulaire No. 176 of 2 December 1959 as a reference text for pigments and colorants. Circulaire No. 176 is available here.
Further, the DGCCRF also notified a draft order on colorants to the European Commission in 2004 (Notification No. 2004/328/F) (’Draft Order’; available here). We understand that the Draft Order will never be enacted into law and should be considered as a “guidance” document only.
Hence, there is currently no positive list applicable to colorants/pigments used in food contact plastics or in other food contact materials in France.