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Official Journal of the European Union

Commission Decision March 17, 2009 requires Member States to ensure the biological insecticide containing dimethyl fumarate (DMF) shall not be put on the market and the products on the market (notice the file number C (2009) 1723) (Content and Europe Related Economic Area) (2009/251/EC) the European Commission, noting the establishment of the European Community "Treaty", note 3 December 2001 issued by the European Parliament and Council Directive 2001/95/EC "on the general products security ", in particular Article 13,
After consultation with Member States, in view of:
 
(1) According to the 2001/95/EC Directive, manufacturers put products in the market must be safe.
 
Several members of the market to sell the furniture and footwear products have been recognized as a hazard to France, Poland, Finland, Sweden and the UK consumer health reasons.
 
(3) According to the clinical trial, this health damage from chemical dimethyl fumarate (DMF) caused. This is a biocide inhibiting mold in wet storage or transportation conditions will lead to deterioration of leather furniture and footwear.
 
(4) DMF mostly found in the furniture inside the small bag, or on the packaging box of shoes. It is volatile and thus penetrate into the product, to prevent mildew products. However, damage to the consumer in contact with the product. DMF penetrate through clothing to the consumer's skin, causing painful contact dermatitis, including itching, irritation, redness and burns; in some cases, even reports of acute respiratory disorders. Especially difficult to treat dermatitis. Therefore, the presence of DMF as a serious hazard.
 
(5) According to Article 13 of Directive 2001/95/EC, if the European Commission noted that some consumer products pose a serious health and safety hazards, based on certain conditions, it can pass a resolution calling on Member States to take measures, aimed in particular restrictions on the market for the product or the product on the market subject to certain conditions.
 
(6) If (a) Member States have adopted or to be used in the methods used to deal with the risks are very different; (b) due to the nature of security issues, according to the relevant applicable to the products developed by Community law other procedures, the risk can not be consistent with the urgency of the event as a way to deal with; and (c) only through the use of appropriate measures at Community level in order to effectively eliminate the risk, you can use this resolution, to ensure that consumers health and safety are sustained and high level of security, while ensuring the proper functioning of the internal market.
        
With leather furniture and a pure patch of dimethyl fumarate in human clinical studies (patch test) showed that the most serious cases, as low as 1 mg / kg will be a strong reaction. Based on this study, the French passed a decree law prohibits seat with dimethyl fumarate and footwear imports and the market. French law also requires, where obviously the product or packaging cushion containing DMF and footwear products, all requirements of the recall. The Act for one year. Belgium based on the same study also published a decree prohibiting all dimethyl fumarate containing articles and products on the market. Spain enacted measures to prohibit all consumer products containing dimethyl fumarate and skin contact. DMF biocides cause serious harm to the health of consumers, Belgium, Spain and France are the only specific regulatory measures have been taken to a member.
 
(9) According to the February 16, 1998 issued by the European Parliament and Council Directive 98/8/EC "biocide products on the market" ("biocide Directive") section 2 (1) (a) of Article , is defined as a biocide products containing active substances and one or more active substance products, the purpose is to destroy chemical or biological means, to stop, so harmless, prevent the occurrence of reaction, or other means of pest body to exert control. Biocides Directive 3 (1) requires Member States, unless biocide products authorized under the Directive, shall not be in the marketing and use of its territory; of the Directive 5 (l) (b) (iii ) provides comparison with other products, and only kill in the biological product of the product itself or its residues on human health have no direct or indirect effects can not be accepted in order to authorize this biocide products. Therefore, the biocide products must meet very high safety standards before they can be authorized.
 
(10) According to the instructions of biocides containing DMF biocide products within the Community has not been authorized. Therefore, in the common body, containing dimethyl fumarate biological products can not legally be used to kill mold products, and therefore the products within the European Union can not legally contain DMF. However, when imported into the Community of the product (or products, raw materials) in the presence of DMF, they were without any restrictions.
 
(11) According to the REACH [the European Parliament and the Council of 18 December 2006 on chemicals released Registration, Evaluation, Authorization and Restriction (REA CH), set up the European Chemicals Agency, amend Directive 1999/45/EC, Abolition of Council Regulation No. 793/93 and Commission Regulation No. 1488/94 and Council Directive No. 76/769/EEC and Commission 91/155/EEC number, 93/67/EEC number, 93/105/EC, and No. 2000 / 21/EC Directive No. No. No. 1907/2006 of the European Union regulations] to implement the restrictions on the DMF is not possible in the short term. Therefore, taking into account the urgency of the current risk management, it can not meet the need.
 
(12) In these cases, Member States should be required to ensure that products containing DMF not on the market or on the market in order to prevent serious harm to consumers until a permanent solution .
 
(13) Determination of the product or product component content of DMF reference to the maximum limit of 0.1mg/kg. This concentration is far lower than 1 mg / kg, and 1 mg / kg concentration in the above-mentioned strong patch test reaction to occur. Therefore, 0.1 mg / kg reasonable solution to the maximum limit of DMF product caused a serious risk.
 
(14) Accordingly, the method used should be able to accurately parts of the product or product concentration of 0.1mg/kg of DMF were quantified. This means that the detection limit should reach 0.1 mg / kg or less than 0.1 mg / kg.
 
(15) Member States must implement a market surveillance and enforcement activities to prevent unsafe products on consumer health and safety hazards.
 
(16) Member States to ensure that the resolution is implemented, manufacturers and dealers to sell only safe products to fulfill obligations. In order to not only meet the interests of Member States, and consistent with the interests of manufacturers and distributors need to have a shorter transition period, and the shorter the more reasonable transition period, it is consistent to prevent more serious damage to consumer health and safety incidents and the need to ensure balance.
 
(17) provided in line with the resolution noted in Article 15 of Directive 2001/95/EC established the Committee. This resolution is hereby adopted:
       
Definitions The following definitions apply to this resolution:
 
(A) "DMF" refers to the chemical dimethyl fumarate, IUPAC (International Union of Theoretical and Applied Chemistry) name for Dimethyl (E)-butenedioate, CAS No.: 624-49-7, Einecs (compound catalog database ) No. :210-849-0.
 
(B) "Product" means Directive 2001/95/EC Article 2 (a) any of the products defined in Article;
 
(C) "Products containing DMF" refers to any of the following products or any product components:
 
(D) declare the presence of DMF, such as a bag or package; or
 
(E) the product or product parts is greater than the concentration of dimethyl fumarate 0.1 mg / kg;
 
(F) "market" means the first time in the Community of the market;
 
(J) "on the market" refers to the process provided in the commercial activities in the Community market for distribution, consumption or use, whether paid or unpaid.
 
The implementation of Article 2


 
1. From May 1, 2009 onwards, Member States shall ensure that the products containing DMF is prohibited on the market or on the market.
 
2. From May 1, 2009 onwards, Member States should ensure already on the market or sold in the market of products containing DMF withdrawn from the market and recall from consumers, and consumers are fully informed of dangers of this product. Member States should be noted in the terms of the measures taken to inform the Committee immediately. Consistent with the provisions of Article 12 of Directive 2001/95/EC.

  
Article 3 Member States shall take the necessary measures notified to comply with this resolution, publish these measures and inform the Board accordingly.
  
The implementation of Article 4 of this resolution will be implemented until March 15, 2010.
  
Article 5 of the resolution, the recipient will be distributed to the Member States.

2013-11-7
   
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