Chemical Legislation Advice and Guidance

legislation advice and guidanceUnderstanding local, national and international chemical legislation can be a challenge for any business manufacturing and supplying products or materials around the world; there are numerous legislative product safety regulations worldwide regarding the placing on the market of products known to contain harmful chemicals. The landscape is complicated and requirements will depend not only on legal jurisdiction but also type of product and age grading (i.e. adult or child).

REACH Regulations

REACH is a European Union Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. REACH aims to give industry greater knowledge about the chemicals it uses and ultimately this contributes to the prevention of health problems caused by exposure to chemicals.

Manufacturers, Importers, Distributors, Retailers and Downstream users all have responsibilities under REACH. In addition to this, substances, preparations and articles are subject to different provisions under REACH.

Substances of Very High Concern (SVHC’s)

SVHC’s are substances of particular concern due to their hazardous properties to human health and/or the environment. These substances include CMR’s (carcinogens, mutagens and toxic to reproduction), PBT’s (persistent, bioaccumulative and toxic) and vPvB’s (very persistent, very bioaccumulative).

At the time of writing, the candidate list of SVHC’s contains 174 chemical substances. Any supplier of articles containing SVHC’s at concentrations of more than 0.1% by weight of the article has to provide available and relevant safety information about the substance to the recipients of these articles. In addition, this information also needs to be provided to consumers within 45 days of a request.

The candidate list is subject to continual development and will keep on to growing. Please refer to this link for an up to date list of SVHC’s

Annex XVII

Annex XVII is a section of REACH dealing with restricted chemicals; these hazardous substances have specific restrictions, and as such certain chemical substances in the specific product are not allowed to be used. You are in breach of legislation if you fail to comply with the restrictions set out in Annex XVII of REACH.

Currently, there are 63 categories of restricted substances in REACH Annex XVII, involving more than 1000 substances. It is the restrictions set out in Annex XVII that form the bases of restricted substance policies.

“Understanding local, national and international chemical legislation can be a challenge for any business…”

California Proposition 65

Originally entitled “The Safe Drinking water and Toxic Enforcement Act”, California Proposition 65 aimed to protect Californian citizens and the states drinking water from chemicals known to cause cancer, birth defects and other reproductive harm. More recently, the act has become a product safety directive meaning that any retailer of a product or service is legally responsible for the chemical content of that product/service.

California Proposition 65 only applies to the state of California, however this includes all products distributed within the state. Therefore, if you are selling or distributing your products into California they must be proposition 65 compliant.

How do I comply with California Proposition 65?

Under the act, businesses are required to provide a “clear and responsible” warning before knowingly and intentionally exposing anyone to a listed chemical. This warning could be on the product itself, on its packaging, or by means of prominent signage at the point of distribution. Once a chemical has been listed businesses have 12 months to comply with the warning requirements.

China GB Standards

Chinese GB standards are Chinese national standards issued by the Standardization Administration of China (SAC), the Chinese National Committee of the ISO and IEC.

Chinese standards may be either mandatory or voluntary. Mandatory standards have the force of law as do other technical regulations in China. They are enforced by laws and administrative regulations and concern the protection of human health, personal property and safety.

Companies doing business in China need to understand and be aware of the complexities and necessary requirements under the vast range of GB standards. Any products being sold in China are required to be tested in order to ensure their compliance.

Monitoring Compliance

RAPEX, a portal for the rapid exchange of information regarding consumer safety in Europe provides data for legal breeches of regulations relating to the REACH and other European legislation.

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