It is 2013—the year of the new cosmetics regulation in the European Union (EU). This “recast” of the 1976 Cosmetics Directive was intended to make things simpler, but does it? In some respects, yes—by clarifying certain parts of the past directive that were open to interpretation. The new regulation also should reduce the number of civil servants required in EU member states, since as an EU law, it does not require local enactment in each separate country. This has to be a good thing, in line with the austerity program, unless one regards it as just another example of the EU’s stealthy take-over of a nation’s sovereignty. However, though it is a good business opportunity for consultants and safety assessors, it is making life much harder, in some respects, for smaller companies that do not have the impressive resources of cosmetic multinationals behind them.
The purpose of this article is to review and comment on the EU’s regulatory position, as of the first half of 2013, on hair dyes—or is it hair colorants?—and will ignore all the other segments addressed by the EU, for now. It will consider how the new regulation may have made this area subject to greater interpretation, rather than less.
A basic mistake: The first Cosmetics Directive 76/768 envisaged a “positives” or approved list for hair dyes, which is hidden among the “whereas” statement in its opening text. The directive states: “Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances, which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization.”
Incidentally, the creation of such a list was, in this author’s opinion, a basic mistake as it assumes the safety/risk associated with the use of a chemical is usually linked to its function. This has led to the curious situation of materials such as those marketed as “NAP” (“not a preservative”) but that have the mysterious emollient function of improving the overall preservation of the product. What is wrong with the simple mandate: Make sure the product is safe for its intended use?
Definitions: The directive partially defines a hair dye in Article 4 part (c), which prohibits the marketing of cosmetic products that contain “coloring agents other than those listed in Annex IV part 1, with the exception of cosmetic products containing coloring agents intended solely to color hair.” It’s interesting that the Annex 4 definition of colorants is “all coloring functions but those intended solely to color hair.” Unfortunately, “coloring”, “dyeing” or “hair” were not defined—i.e., is coloring the same as dyeing? The meanings are not the same in English but in other languages, one word may be used to cover both functions. Further, does hair refer to that on the head, in the eyebrows or eyelashes, or on the chest, legs or genital areas?
Interim regulation of hair dyes: Since it was unable to create a positive list due to lack of data, the EU Commission requested that the industry produce safety dossiers for hair dyes, initially in a rather informal fashion. This effort was coordinated by the European cosmetics association COLIPA, now Cosmetics Europe, via a sub-committee made up of representatives from the major multinational hair color product companies—which this author happily served for 12 years. Over the years, the process became more formal, and resulted in a “hair dye strategy,” the progress of which is described somewhat briefly on the European Commission (EC) website.1 As of February 2010, this strategy has resulted in a list of 123 “supported” hair dyes, i.e., those for which the industry provided the required information in the form of dossiers. This list seems to supersede the list of 117 dyes cited on the website for which safety dossiers have been or are being produced.
Without a “positives” list, over the last 36 years, a number of hair dyes have been regulated in the EU either through Annex II, as banned, or Annex III, as restricted. In general, materials have been banned due to lack of interest and demand rather than real safety concerns. The set of restricted hair dyes listed in Annex III is an embryonic list.1 However, several hair dyes have received favorable opinions from the EC’s Scientific Committee for Consumer Safety (SCCS), although those dyes have yet to make it onto Annex III.
Cosmetics Regulation 1223/2009 attempted to complete the hair dye “positives” list by foreseeing its inclusion in Annex IV. Unfortunately, this is where things become more confusing. The important relevant sections of the regulation, paraphrased here, are:
• Whereas 26, stating there will be “positives” list for colorants (Annex IV);
• Whereas 27, stating that to avoid ambiguities (!), colorants are defined as substances that color through absorption and reflection and not though chemical reaction; and
• Whereas 28, stating that Annex IV “is currently restricted to skin colorants,” which it is not, and “should include hair colorants once the assessments have been finished.”
These “whereas” statements do not have any legal weight, and are only included to set the scene for the legally binding parts of the whole regulation, which are listed in the subsequent “chapters.” The following statements are legally binding:
• Article 2 (Definitions), part (m): Colorants are substances designed to color the product, the body as a whole, or certain parts thereof. In addition, precursors of oxidative hair colorants are deemed colorants.
• Chapter IV, Article 14, part 1 (c): This section prevents the use of colorants other than those listed in Annex IV.
• Chapter IV, Article 13, part 2: “Subject to a decision of the Commission to extend the scope of Annex IV to hair coloring products, such products shall not contain colorants intended to color the hair other than those listed in Annex IV, and colorants intended to color the hair which are listed there but not used in accordance with the conditions laid down in that Annex.” [This statement probably relates to when hair dyes are added into Annex IV.]
• Preamble to Annexes II to VI, part (c): “Hair product” means a cosmetic product intended to be applied on the head or face, except the eyelashes.
“Whereas” statements 27 and 28 and the colorant definition are somewhat contradictory, but the colorant definition should be legally relevant. Interestingly, the term dye is not used in the directive, which may have been intended to clarify the terms, or may be the result of translation to English from another language where this distinction is not present. Clear definitions for colorant and dye—i.e., something intended to give lasting color to a substrate—could have been very useful here. It would also seem that no existing Annex IV colorants can be used in a hair colorant product. Under the directive, temporary hair colorant products that wash off after use, such as hair mascaras, were usually made from Annex IV colors and labelled with their CI numbers. However, this may no longer be allowed.
The positive list for more permanent hair dyes will not be ready by July 2013, and may follow in approximately 18-24 months, as all the final opinions have yet to be completed. Updates to the annexes, i.e., published changes to the directive, were expected prior to July but any errors in the regulation are not expected to be addressed. One can only hope that the Competent Authorities managing trading standards in the U.K. will be understanding and not take action where matters are trivial.
Regarding sites/areas to which colorants/dyes may be applied, questions have risen as to their application on eyelashes, and this is the subject of a recent dossier and opinion from the SCCS—and as of May 2013, the industry awaits this decision. Also, a definition for hair is given that does not mention genital or chest hair, but it would seem that hair colorants would not be allowed for use on these areas.
What to do?
From this overview, it is clear that the objective of removing differences in interpretation has not yet been sufficiently met. As the industry moves further into the sunlit uplands of regulated 2013, what is the hair colorant product manufacturer to do? Some advice might be as follows.
• Use the “approved” hair dyes listed in Annex III; • Use hair dyes that have a favorable opinion from the SCCS;
• Avoid hair dyes that are not on the EU supported list;
• Make informed decisions with respect to “temporary” hair coloring products and use current suitable Annex IV colorants—and be prepared to defend these choices;
• Don’t worry about new hair dyes coming onto the market in the near future, as the complete animal testing ban also comes into force in 2013 and the SCCS still demands tests that require animals; and
• Above all, be sure to have satisfactory safety assessments from suitably qualified safety assessors—after all, this really is the thing that matters.
Has the new regulation clarified the situation with respect to hair dyes? Probably not. Will the new legislation be less subject to different interpretations? This author knows what his money is on. This all may seem rather confusing—it’s even confusing to regulatory experts. In fact, this author’s interpretation may turn out to be different from what eventually becomes common practice. That’s the EU for you.
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1. Consolidated EU Cosmetics Directive and subsequent adaptations, available at: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1976L0768:20100301:en:PDF (Accessed May 21, 2013)