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COMMISSION DECISION
of 17 March 2009
requiring Member States to ensure that products containing the biocide dimethylfumarate are not
placed or made available on the market
(notified under document number C(2009) 1723) (Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES, DMF was most often contained in little pouches fixedinside the furniture or added to the footwear boxes. Itthus evaporated and impregnated the product, protectingit from moulds. However, it then also affected consumerswho were in contact with the products. DMF penetrated Having regard to the Treaty establishing the European through the clothes onto consumers’ skin (2) where it caused painful skin contact dermatitis, including itching,irritation, redness, and burns; in some cases, acuterespiratory troubles were reported. The dermatitis wasparticularly difficult to treat. The presence of DMF isthus a serious risk.
Having regard to Directive 2001/95/EC of the EuropeanParliament and of the Council of 3 December 2001 ongeneral product safety (1), and in particular Article 13 thereof, Under Article 13 of Directive 2001/95/EC, if theEuropean Commission becomes aware that certainproducts present a serious risk to the health and safetyof consumers, it may, subject to certain conditions, adopta decision requiring Member States to take measures intended in particular to restrict or make subject tospecific conditions the availability on the market ofsuch products.
Pursuant to Directive 2001/95/EC producers are obligedto place only safe consumer products on the market.
Such a decision may be adopted if (a) Member States Furniture and footwear available on the market in several differ significantly on the approach adopted or to be Member States have been identified as the cause of adopted to deal with the risk concerned; (b) the risk damage to the health of consumers in France, Poland, cannot, in view of the nature of the safety issue, be dealt with in a manner compatible with the degree ofurgency of the case under other procedures laid down bythe specific Community legislation applicable to theproduct concerned; and (c) the risk can be eliminatedeffectively only by adopting appropriate measures According to clinical tests the health damage was caused applicable at Community level, in order to ensure a by the chemical dimethylfumarate (DMF), a biocide consistent and high level of protection of the health and safety of consumers and the proper functioning of furniture or footwear during storage or transport in a (2) Williams J.D.L., et al. (2008), ‘An outbreak of furniture dermatitis in the UK’, British Journal of Dermatology 159: p. 233-234.
A clinical study on humans (1) (patch tests) with leather Directive. Thus, biocidal products containing DMF are furniture and patches of pure DMF showed strong not legally available in the Community for the reactions in the most severe case down to 1 mg/kg.
treatment of products against moulds, and thus no On the basis of this study, France adopted a decree (2) product manufactured in the EU can legally contain which bans the importation and placing on the market DMF. However, there is no restriction when DMF is of seating and footwear containing DMF. The French present in products (or raw materials of products) that decree also requires the recall of all seating and footwear which visibly contains, or the packaging ofwhich visibly contains, DMF. The duration of thedecree is limited to 1 year. Belgium issued a decree (3),on the basis of the same study, which bans the placingon the market of all articles and products containingDMF. Spain issued measures (4) banning DMF in all Any restriction of DMF to be put in place under Regu­ consumer products coming into contact with the skin.
lation (EC) No 1907/2006 of the European Parliamentand of the Council of 18 December 2006 concerning theRegistration, Evaluation, Authorisation and Restriction ofChemicals (REACH), establishing a European ChemicalsAgency, amending Directive 1999/45/EC and repealing Belgium, Spain and France are the only Member States Council Regulation (EEC) No 793/93 and Commission having adopted specific regulatory measures to address Regulation (EC) No 1488/94 as well as Council the serious risk to consumer health from the biocide 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (6)would be impossible in the short term and would thusnot suffice with regard to the urgency of the present riskmanagement need.
Under Article 2(1)(a) of Directive 98/8/EC of theEuropean Parliament and of the Council of 16 February1998 concerning the placing of biocidal products on themarket (the Biocides Directive) (5), biocidal products aredefined as active substances and preparations containingone or more active substances, which are intended to In these circumstances, Member States should be required destroy, deter, render harmless, prevent the action of, to ensure that no products containing DMF are placed or or otherwise exert a controlling effect on any harmful made available on the market, in order to prevent the organism by chemical or biological means. Article 3(1) of serious risk posed by these products to consumers, until the Biocides Directive requires Member States to a permanent solution becomes available.
prescribe that a biocidal product shall not be placed onthe market and used in their territory unless it has beenauthorised in accordance with the Directive; andArticle 5(1)(b)(iii) of the Directive provides thatMember States shall authorise a biocidal product onlyif, amongst other things, it has no unacceptable effects The presence of DMF in products should be determinedagainst the maximum limit of 0,1 mg DMF per kg of itself or as a result of its residues, on human health, product or part of the product. This is considered to be directly or indirectly. Thus, very high safety standards sufficiently below the concentration of 1 mg/kg which have to be fulfilled before a biocidal product can be showed a strong reaction in the patch tests mentioned above. The maximum limit of 0,1 mg/kg thus appro­priately addresses the serious risk from DMF in products.
Biocidal products containing DMF are not authorised inthe Community in accordance with the Biocides Accordingly, the analytical method employed should be (1) Rantanen T. (2008), ‘The cause of the Chinese sofa/chair dermatitis epidemic is likely to be contact allergy to dimethylfumarate, a novel able to reliably quantify 0,1 mg DMF per kg of product potent contact sensitizer.’ Concise communication, British Journal of or part of the product. This means that the method’s quantification limit should be 0,1 mg/kg or less.
(2) Ministry for the Economy, Industry and Employment, Decree of 4 December 2008 suspending the placing on the market of seatsand footwear containing DMF from the market. JORF (FrenchOfficial Journal), 10 December 2008, Text 17 of 108.
(3) The Minister for Public Health and the Minister for Consumer Protection, Ministerial Decree concerning the prohibition ofplacing articles and products containing DMF on the market.
Member States must carry out market surveillance and enforcement activities to prevent risks posed by unsafe products to the health and safety of consumers.
(4) Resolution of 22 December 2008 of the National Consumer Institute BOE (Spanish Official Journal) No 18, 21 January 2009,Sec. V-B, p. 5474.
(6) OJ L 396, 30.12.2006, p. 1, as corrected by OJ L 136, 29.5.2007, A short transition period is necessary in the interests of both the Member States, who must ensure that thisDecision will be applied, and producers and distributors Implementation
who are subject to the obligation to make available on As of 1 May 2009 Member States shall ensure that the market only safe products. The shortest possible tran­ products containing DMF are prohibited from being placed or sition period is appropriate, consistent with the need to prevent further incidents of serious damage to the healthand safety of consumers and to ensure proportionality.
As of 1 May 2009 Member States shall ensure that The measures provided for in this Decision are in products containing DMF and already placed or made accordance with the opinion of the Committee estab­ available on the market are withdrawn from the market and lished by Article 15 of Directive 2001/95/EC, recalled from consumers, and that consumers are adequatelyinformed of the risk posed by such products.
Member States shall inform the Commission without delay of the measures taken under this Article in accordancewith Article 12 of Directive 2001/95/EC.
Definitions
For the purposes of this Decision the following definitions shallapply: Information
(a) ‘DMF’ means the chemical dimethylfumarate, with the Member States shall take the necessary measures to comply IUPAC name Dimethyl (E)-butenedioate, the CAS No with this Decision, publish those measures and inform the (b) ‘product’ means any product as defined in Article 2(a) of Period of application
(c) ‘product containing DMF’ means any product or any part of This Decision shall be applicable until 15 March 2010.
(i) the presence of DMF is declared, such as on one or Addressees
(ii) the concentration of DMF is greater than 0,1 mg/kg of This Decision is addressed to the Member States.
the weight of the product or part of the product; (d) ‘placing on the market’ means the first making available of a (e) ‘made available on the market’ means supplied for distri­ bution, consumption or use on the Community market inthe course of a commercial activity, whether in return for

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