On 28 January 2012, the Official Journal of the EU published Decision 2012/48/EU of the European Commission extending the validity of Decision 2009/251/EC, which bans all products that contain the biocide Dimethylfumarate (DMF) from being placed on the EU market.
Hong Kong’s exporters will recall that Decision 2009/251/EC was adopted in March 2009 after DMF was found to be the cause of severe allergic reactions reported by consumers in France, Poland, Finland, Sweden and the UK. The Commission, by means of this Decision, required Member States to ensure that products containing the biocide DMF were not placed or made available on the market and, furthermore, to secure the withdrawal from the market of the products containing the sensitising substance as from 1 May 2009.
DMF has been used in the packaging of footwear, furniture and electronics to prevent the proliferation of mould that may cause, among others, leather components or articles to deteriorate during storage and transportation in humid climates. It is traditionally contained in little pouches fixed inside the furniture or added to footwear boxes, where it evaporates, impregnating the product and, consequently, entering into contact with consumers through their skin. It can produce painful skin contact dermatitis, itching, irritation, redness and burns, as well as, in some cases, breathing difficulties.
Hong Kong sellers may recall that DMF was already banned in products that were being manufactured in the EU by Directive 98/8/EC (the Biocides Directive), although, up to the adoption of Decision 2009/251/EC in 2009, foreign manufacturers were allowed to utilise DMF in the products they exported to the EU.
The 2009 ban was first introduced under Article 13 of Directive 2001/95/EC (the Directive on General Product Safety), considering that other mechanisms to control the distribution of the substance at EU level would not operate quickly enough to guarantee consumer safety from the risks posed by DMF. Article 13 restricts the validity of a measure to a one year period, but it may be renewed for additional periods none of which shall exceed one year.
Since no definitive solution has been found, the period of application of the Decision (which has already been extended twice) has been extended once again by the Commission through Decision 2012/48/EU adopted on 26 January 2012. Accordingly, the ban shall apply until 15 March 2013; however, this period may well be extended once more unless a permanent regulatory solution is agreed.
In this respect, Hong Kong traders should be informed that in September 2011, following a favourable opinion of the European Chemical Agency’s Committee for Socio-Economic Analysis, the Commission published a draft Regulation aimed at prohibiting definitively the use of DMF in consumer products within the EU. According to the proposed text, DMF will be inserted into Annex XVII of the EU’s REACH Regulation (“Restrictions on the manufacture, placing on the market and use of certain dangerous substances, preparations and articles”), making the restriction of the substance permanent and uniform throughout the EU. A general EU-wide measure is believed to be the most appropriate method of reducing risks to consumers, in contrast to the present ad hoc regime. The draft is currently being analysed by a committee of Member State representatives.
Hong Kong sellers must already be aware that Commission Decision 2009/251/EC is applicable to all goods intended for consumers or likely to be used by them even if not intended for them. For the scope of the prohibition, a “product containing DMF” means any product or part of a product where either the presence of DMF is declared, such as on one or more pouches, or the concentration of DMF is greater than 0.1 mg/kg of the weight of the product or part of the product.
Member States have to comply with this decision by 15 March 2012, which effectively means that they are obliged to prolong the ban on their territory for a further year. The text of Decision 2012/48/EU may be accessed via the following link:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:026:0035:0035:EN:PDF
In addition, the Commission’s draft Regulation for a permanent ban can be accessed via the following link:
http://ec.europa.eu/transparency/regcomitology/index.cfm?do=search.documentdetail&8iG2MInZ9xCJ12UkcYAHqBWdJ4cTOT+8CQ0Iml4VQOCUyRNldL7I/SVpCmnySTSZ
