We and our analytics and advertising providers may use cookies and similar technologies to enhance the browsing experience, facilitate sharing of content, and generate statistics about use of the website. For more information or to change your preferences, click here.
TSCA Reform Center PackagingLaw.com
PackagingLaw.com
TSCA Reform Center
Professionals By Name
Professionals By Practice Area
Professionals By Location
Business Counseling and Transactional
Chemical Control REACH
Environmental and Toxic Tort Litigation
Food and Drug
Cannabis, Hemp, and Cannabinoids (CBD)
Food Litigation
Tobacco and E-Vapor
Health and Safety Compliance Audit
International Regulatory Affairs
Nanotechnology Strategy, Regulation and Defense
Biocidal Products Regulation (BPR)
Privacy and Internet
Product Stewardship, Green Chemistry and Sustainability
EU Offices
Benefits for our U.S. Based Offices
The Regulation of Colorants Intended for Food Contact Applications in the European Union
Colorants used in the manufacture of materials and articles intended for food contact applications in the European Union (EU) are not yet specifically regulated at the EU level. In other words, there is currently no Union-wide directive or regulation specifically regulating such colorants, used to import colors to plastics, paper, coatings, and other types of materials used in contact with food.
First, as in most jurisdictions, manufacturers of finished food contact materials or articles must ensure that any colorants or pigments used do not color the food they contact. Manufacturers and distributors of colored food contact materials and articles must review their products to determine that they meet the general safety requirements of the Framework Regulation when used as intended. As part of the general safety assessment, it would be advisable to establish that the colorant(s) being used meets the applicable purity specifications in one or more EU Member States and/or in the Council of Europe Resolution AP(89)1 on colorants. The details of an assessment of these colorants when used in the EU Member States is discussed below.
1. Harmonized EU legislation applicable to colorants used in the manufacture of food-contact materials and articles
At the EU level, all food contact materials and articles containing colorants must comply with the Framework Regulation (EC) No 1935/2004, as amended, which is the overarching legislation that applies to all food contact materials or articles placed on the market in the EU. Article 3.1 of the Framework Regulation sets out that materials and articles shall be manufactured in accordance 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 the food, or c) bring about a deterioration in its organoleptic characteristics. Further, all colored materials and articles, intended for food contact applications, must be manufactured in accordance with the requirements of Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food, as amended.
(a) The regulation of colorants used in the manufacture of plastic food contact materials and articles
The Plastics Regulation (EU) No 10/2011, as amended, specifically regulates plastic materials or articles intended to be placed on the market in the EU. With respect to colorants used in plastic materials and articles, Article 6.2 of the Plastics Regulation outlines that "colorants (…) may be used in the manufacture of plastic layers in plastic materials and articles subject to national law." In other words, colorants used in plastic materials and articles are not subject to the positive list requirements of the Plastics Regulation, although, if they are listed on the Plastics Regulation (as is the case with carbon black, for instance), then it would be advisable to demonstrate that they meet applicable restrictions or specifications as part of the safety assessment.
Some restrictions set out in the Plastics Regulation may also indirectly apply to colorants used in plastic food contact materials and articles because they set purity specification or migration limits pertinent to a determination of the safety of the use of the colorant. For example, Annex II of the Plastics Regulation sets out that plastic materials and articles shall not release primary aromatic amines (PAAs) in a detectable quantity into food, and prescribes a detection limit a 0.01 mg/kg for the sum total of PAAs (apart from those specifically listed in the Plastics Regulation's positive list). Further, Annex II of the Plastics Regulation also sets specific migration limits for barium, cobalt, copper, iron, lithium, manganese, zinc, aluminium and nickel in the final plastic materials or articles.[1]
Some colorants may form PAAs or contain the aforementioned elements. Given that the Plastics Regulation does not specify or restrict the origin of PAAs or these elements, migration from colorants in plastic materials or articles would also need to be taken into consideration in determining whether applicable restrictions for these substances are met.
Finally, it is noteworthy that Germany maintains non-legally binding purity requirements for colorants used in the manufacture of polymeric food contact materials and articles. These are set out in BfR Recommendation IX (Colorants for Plastics and other Polymers Used in Commodities). While Germany's Recommendations are not legally binding, they are widely regarded and should be consulted as informative to a safety decision.
(b) Colorants used in the manufacture of food contact materials and articles other than plastics
As already mentioned, there is also no harmonized legislation specifically regulating the use of colorants in the manufacture of food contact materials and articles other than plastics at the EU level. That said, it is noteworthy that the European Commission is working on a draft harmonized measure on printed food contact materials and articles. While not applicable to colorants, this measure may establish some principles that may affect this issue in the future.
The new measure is not expected to regulate printed food contact materials through a strict positive list system. Nonetheless, it is possible that it will further address pigments/colorants used in the manufacture of printing inks, particularly as the draft German Printing Inks Ordinance (now on hold) is one of the sources that the EC is referring to, and this draft Ordinance did propose to specifically regulate such colorants/pigments. For further information regarding the regulation of printing inks in the EU, please refer to our article dedicated to this subject at the following link: http://www.packaginglaw.com/special-focus/regulation-printing-inks-european-union.
2. Member State Requirements
(a) Plastics
In accordance with Article 6.2 of the Plastics Regulation, one must turn to the requirements of the individual Member States to assess whether each EU Member State explicitly permits the use of a specific colorant in plastic food contact articles.
To our knowledge, no Member State maintains a positive list of components permitted for use as colorants/pigments. In the past, Circulaire No. 176 of 2 December 1959 on pigments and colorants intended for use in plastic materials and packaging, was the reference text in France for assessing whether colorants used in plastic materials and articles complied with French food contact legislation. However, this text must now be deemed to be repealed.[2]
France also notified a draft Order on colorants to the European Commission (EC) in 2004.[3] However, the French competent authorities, the DGCCRF,[4] have indicated that this draft Order will never be enacted into law and should be considered as a "guidance" document only. Hence, France does not currently maintain legally binding legislation specifically regulating colorants used in plastics, or in any other type of food contact material or article. That said, listings on the aforementioned 2004 draft Order or in Circulaire No. 176 of 2 December 1959, may be helpful when conducting a safety assessment of colorant(s) intended for use in plastics (or in other food contact materials or articles).
Several Member States maintain national purity requirements for colorants used in plastic materials and articles (for example, Italy, the Netherlands, Greece, the Czech Republic and Romania). In general, these requirements are related to the presence of antimony, arsenic, barium, cadmium, chromium and other heavy metals, as well as aromatic amines and some other specific organic compounds of concern. (Although, the Dutch legislation also places specific migration limits on elements migrating from the final colored food contact material or article.) The specific requirements vary slightly country by country. Such purity requirements must be complied with if the colorant itself, or a product containing the colorant, is first manufactured or placed on the market in a Member State maintaining purity requirements for colorants.
(b) Food contact materials and articles other than plastics
While most of the purity requirements for colorants at Member State level specifically target colorants used in the manufacture of plastic materials and articles, it is worth recalling that this is not always the case. For example, the Dutch purity requirements for colorants apply to all food contact materials and articles containing colorants being placed on the market in the Netherlands. Similarly, Spain has purity requirements applicable to colorants but only for ones used in the manufacture of polymeric materials and articles that are not specifically regulated at the EU level (adhesives, elastomers and natural and synthetic rubber, ion-exchange resins, silicones, varnishes and coatings and waxes). Finally, Slovakia has purity requirements for dyes/pigments used in the manufacture of printing inks, while Romania has purity requirements for colorants used in the manufacture of both printing inks and plastic.
However, irrespective of whether the colorant is used in the manufacture of plastic or another food contact material, in the event that a colorant does not exactly comply with the applicable purity requirements in a particular Member State (given that purity requirements vary slightly between Member States), then it would be possible to firstly legally place the colorant itself or a product containing the colorant on the market in a Member State that does not have specific purity requirements for colorants (or in a Member State in which the colorant complies with the purity requirements) and market. Thereafter, that colorant could be legally marketed in Member States maintaining purity requirements that the colorant does not comply with, based on the principle of mutual recognition.
Many Member States do not maintain national requirements for colorants. However, as noted above, it must always be ensured that the finished food contact material or article intended to come into contact with food containing the colorant(s) complies with the requirements of the Framework Regulation (EC) No 1935/2004, in particular the safety requirement set out in Article 3.1 a) of that Regulation.
3. Council of Europe Criteria
In addition to the legislation at Member State level, the Council of Europe (CoE) Resolution on the use of colorants for food contact plastics also identifies purity criteria (see "Council of Europe resolution AP(89)1 on the Use of Colourants in Plastic Materials Coming into Contact with Food"). By way of background, the Council of Europe (CoE) consists of 47 countries, including the 28 EU Member States. The CoE has adopted resolutions with respect to many different types of food contact materials. Although CoE Resolutions on food contact materials are not legally binding, these Resolutions are, in practice, widely used in demonstrating safety of colorants used in food contact materials. In particular, the purity specifications set forth in CoE Resolution AP(89)1 are often viewed by customers as a valuable guide to establishing the safety of materials for use in food contact applications throughout Europe.
The recommendations set forth in CoE Resolution AP(89)1 include the following:
Colored plastic food contact materials should not, by reason of their coloration, pose a risk to human health or bring about a deterioration in the organoleptic characteristics or an unacceptable change in the nature, substance, or quality of contacted food.
Colorants should be sufficiently integrated into the plastic articles so as to preclude any visible migration of the colorants into contacted food.
Colorants should comply with set limits for heavy metals, primary unsulfonated aromatic amines, sulfonated aromatic amines and extractable polychlorinated biphenyls (PCBs) content.
The use of inorganic cadmium pigments should be restricted to those applications in which their special technological advantages cannot be met by alternative products.
Thus, the EC has not yet harmonized requirements applicable to colorants used in food contact plastics or other food contact materials. The use of these colorants must always be in full compliance with the safety requirements of Article 3 of the Framework Regulation (EC) No 1935/2004. In addition, the finished food contact material or article must otherwise fully comply with the applicable requirements, taking into consideration the presence of the colorant in the food contact material or article. Colorants being used in food contact materials intended for the EU market should also comply with the purity requirements in at least one EU Member State or in the above referenced Council of Europe Resolution.
Finally, business operators should also determine whether it would be necessary to rely on the mutual recognition principle as the basis for marketing colorants or food contact materials and articles containing colorants, in one or more EU Member States, to ensure that they are placing colorants/food contact materials or articles containing colorants on the market in the EU in full compliance with national requirements.
This article is reprinted from Food Packaging Bulletin Issue 6 with the permission of the publisher Research Information.
[1] The SML for aluminium was introduced by the seventh amendment to the Plastics Regulation (Regulation (EU) 2016/1416) and will apply from September 14, 2018, while the SML for nickel was introduced by the eight amendment to the Plastics Regulation (Regulation (EU) 2017/752) and will apply from May 19, 2019
[2] French Decree No. 2008-1281 of 8 December 2008 regarding the publication conditions of instruction notes and circulaires (Décret no 2008-1281 du 8 décembre 2008 relatif aux conditions de publication des instructions et circulaires) .
[3] See "Order on the colouring of plastic materials and articles, varnishes and coatings intended to come into contact with foodstuffs, food products and drinks for human and animal consumption" ("the draft Order"). The draft Order was notified to the EC in 2004 under reference 2004/328/F. It is available on the Commission's Technical Regulations Information System database at the following link: http://ec.europa.eu/growth/tools-databases/tris/en/search/?trisaction=search.detail&year=2004&num=328.
[4] Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes (General Directorate for Fair Trading, Consumer Affairs and Fraud Control).
Devon Wm. Hill
Hazel O'Keeffe
Food & Drug
Updated Privacy and Cookies Policy
Extranets
© 2020 Keller and Heckman LLP. All rights reserved