On 10 and 13 October 2009, two Commission Directives were published in the EU’s Official Journal, amending the law relating to the labelling of toothpaste, and the authorisation of certain ingredients in hair dyes. The framework EU law covering these matters is Council Directive 76/768/EEC concerning cosmetic products. Hong Kong sellers distributing these products on the EU market will already be aware that the term cosmetics, for the purposes of the Directive, includes (among products such as soaps, skin creams, lotions, gels and make-up powders) hair dyes and other hair care products, and products for the care of the teeth and the mouth.

Commission Directive 2009/129/EC on toothpaste labelling: Hong Kong’s toothpaste sellers will most likely be cognisant of a current requirement, introduced by a 2007 Directive (2007/53/EC) for a warning which must be printed on the label of toothpastes that contain fluoride. The 2007 Directive came about pursuant to a recommendation from the EU’s scientific committee (previously known as the SCCP, now the SCCS) regulating consumer products. The recommendation opined that the maximum permitted concentration of 0.15% fluoride does not pose a safety concern when used by children under 6 years of age. Nonetheless, unless the toothpaste label states that it is for adult use only, a warning must be printed on the labelling to the effect that children of 6 years or less may use a pea-sized amount for supervised brushing.

The requirement in the 2007 Directive refers, however, to the content of fluoride, and not to elemental fluorine which – according to the SCCS – is the correct term. As a result of the reference to fluoride, not all fluorine-containing compounds that are subject to conditions for use in cosmetics placed on the EU market, as mentioned in part 1 of Annex III of framework Directive 76/768/EEC, are covered by the 2007 Directive’s labelling requirement.

In order to ensure legal certainty, new Directive 2009/129/EC, published on 10 October 2009, sets out a clarification, namely, that the labelling requirement refers to all 20 compounds containing fluorine, which are listed in part 1 of Annex III to framework Directive 76/768/EEC, and not only those containing fluoride. Hong Kong’s cosmetics sellers who may be wondering how this new requirement will apply to them should note that, while the wording on the label will not change, the need for it will, in principle, apply to a broader range of fluorine-containing products.

The wording to be used (unless the label already indicates the product is only for adult use) continues to be as follows: “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor”.

Member States have until 15 April 2010 to transpose new Directive 2009/129/EC. They must then implement the transposed provisions from 15 October 2010. This latter date will therefore be the date on which Hong Kong businesses will need to begin complying with the provisions. Directive 2009/129/EC can be accessed at:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:267:0018:0019:EN:PDF

Commission Directive 2009/130/EC on hair dyes: This Directive, published on 13 October 2009, comes about pursuant to some new recommendations by the EU scientific committee (the SCCS) advising the European Commission. The SCCS had previously, together with the Commission and Member States, devised an overall strategy to regulate substances that are used in hair dyes. According to this strategy, the industry has, over recent years, been required to submit files containing data on their hair dye products, for evaluation by the SCCS.

The substances p-Phenylenediamine (PPD) and toluene-2,5-diamine (PTD) are currently regulated as being allowed in hair dye products, subject to warnings printed on the label. The SCCS classified these substances as extreme sensitisers contributing to a great extent to the incidence of skin allergies among consumers. The risk assessment of the submitted additional data on PPD and PTD, and final decisions made by the SCCS on the safety of these substances, might still require a considerable amount of time. As a precautionary measure, to reduce the risk of allergies to hair dye products among consumers, the maximum authorised concentrations of PPD and PTD will have to be decreased.

Thus, the requirement spelt out under new Directive 2009/130/EC for PPD and PTD are as follows: after mixing under oxidative conditions the maximum concentration applied to hair must not exceed, calculated as free base, 2% (in the case of PPD) and 4% (in the case of PTD). Hong Kong’s businesses exporting cosmetics to the EU will need to be alerted to this new reduction in the maximum concentrations for PPD and PTD in the hair dye products for which they are used.

Directive 2009/130/EC also clarifies that, in respect of the substance hydroquinone,  Commission Directive 2008/88/EC already banned its use in oxidative hair dye products. In consequence, in the interests of clarity, the previously authorised concentration of 0.3% and the conditions of use and warnings which had to be printed on the label need to be deleted as well, from the relevant part of framework Directive 76/768/EEC.

Member States have until 15 April 2010 to transpose Directive 2009/130/EC into their national laws. Its provisions must then be implemented from 15 July 2010, which is the date on which Hong Kong’s businesses involved with the sale of hair dyes in the EU will have to start complying with the provisions. Directive 2009/130/EC can be accessed at:

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:268:0005:0008:EN:PDF