EU Bans Dimethyl Fumarate

How can you demonstrate that you comply with the regulation?


Business Challenge

Several European Union (EU) countries such as France, Finland, Poland, Sweden and the United Kingdom have reported consumers suffered serious health problems after having a direct exposure to Dimethyl Fumarate from their consumer products. Common symptoms include itchy skin, irritation, redness, burns, and even acute respiratory problems in some serious cases. The European Commission decided on 17 March, 2009 to ban the use of this antifungal
agent in all types of consumer products. From 1 May, 2009, a product or part of a product containing more than 0.1 mg/kg of Dimethyl Fumarate is prohibited from being placed or made available on the EU market. Furthermore, any product which contains Dimethyl Fumarate, that has already been placed or made available on the market, have to be withdrawn and even recalled. How can you determine if Dimethyl Fumarate exists in your products? If Dimethyl Fumarate is found, how can you verify if the amount of Dimethyl Fumarate is below the regulatory threshold?

Solution

To help you determine if your products are within the legal limit, Bureau Veritas has developed a reliable and cost effective test to detect Dimethyl Fumarate. We have a global network of laboratories to provide analytical Dimethyl Fumarate testing. Our knowledgeable laboratory staff can help you to identify Dimethyl Fumarate and implement solutions for various materials which are likely to contain Dimethyl Fumarate.

What are the key benefits?
Support your compliance with the Dimethyl Fumarate regulation
Reduce the risk of potential recalls, fines and litigation
Reduce consumer complaints and media exposure
Protect your reputation and brand equity in the market

Our Approach

Bureau Veritas has knowledgeable and experienced professionals in chemical risk management who are capable of satisfying the specific technical compliance assessment needs of your industry. We offer the following services to help you demonstrate compliance to the Dimethyl Fumarate chemical regulation:

• Category Review Services
-Identify the risk level of your product categories:
• High risk product categories:
-Products susceptible to mold growth (e.g., organic or natural materials) exposed to humid climate AND which have prolonged skin contact (e.g. leather shoes, leather bags, leather furniture, bracelet, plush-toys, etc.)
-Items containing desiccating sachets with Dimethyl Fumarate (e.g. silica gel)

• Dimethyl Fumarate Testing
-Detect if Dimethyl Fumarate exists in your products using reliable established industry methods
-Identify if a product or part of a product containing Dimethyl Fumarate is less than 0.1 mg/kg

Why Choose Bureau Veritas?

Reputation
For over 30 years, we have worked successfully with top manufacturers and retailers around the world to help them better manage risk and regulatory compliance.

Worldwide Locations
With locations close to sourcing and importing areas in over 40 countries, we offer you the convenience of global coverage with local service.

Technical Knowledge & Leadership
Our staff participates in the development of international, industry and regulatory standards worldwide, keeping you and us at the forefront of changes in safety requirements and testing methods.

Personalized Service
At Bureau Veritas, we are committed to meeting your needs and providing you with the highest levels of service.

FAQ - Frequently Asked Questions

What is Dimethyl Fumarate?
Dimethyl Fumarate, a fine white crystalline powder with CAS no. 624-49-7, is used in consumer products to avoid the growth of mold fungus. Dimethyl Fumarate is often added as part of a sachet to leather products and can often be found within a shoe box or leather bag. It is also found within the materials of leather furniture like sofas or chairs. Contamination by desiccating sachets containing Dimethyl Fumarate such as silica gel is currently considered as a potential cause of exposing Dimethyl Fumarate to consumers. These products are largely used for a wide variety of articles such as footwear, textiles, or plush-toys (to prevent mold growth) during shipment.

Why has Dimethyl Fumarate been used so widely in consumer products?
Any natural materials (such as leather, paper, organic textiles, etc.) in your products are prone to mold forming when exposed to humid climate for a period of time. Dimethyl Fumarate has been commonly used as a fungicide in these products. We recommend that you contact us to find out more about our Dimethyl Fumarate testing package and category review services to see how we can help you to comply.
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