Section 8 of REACH regulation details the restriction on certain dangerous substances, and preparations or articles which are manufactured, used and placed on the EU market. Any substance which is used as a substance or in preparations shall be restricted in EU, as long as the use of the substance poses an unacceptable risk to human health or the environment.

Currently, there are 59 categories of restricted substances in REACH Annex XVII, involving more than 1000 substances. These hazardous substances have specific restrictions, and as such certain chemical substances in the specific product are not allowed to be used, so as to avoid any unnecessary testing. Typical hazardous substances that are restricted in products include lead, AZO dyes, DMF, PAHs, Phthalates, PFOS, the nickel release and so on.

Since the XVII of REACH regulation took into force in 2009, the following directives have been replaced:

• Azocolourants Directive 2002/61/EC
• “Blue Colourant” Directive 2003/3/EC
• Cadmium Directive 91/338/EEC
• Nickel Directive 94/27/EC
• Phthalates Directive 2005/84/EC

Impact of REACH restriction List

A restriction of a substance is any condition for prohibition of or concerning, its manufacture, use or placing on the market. Restrictions enable risk management measures beyond those already implemented by manufacturers, importers and downstream users, to be introduced across the Community, where they are determined to be necessary. Restrictions can also impose a harmonized level of risk management measures. Restrictions apply to all manufacturers, importers, downstream users and distributors of a substance if the manufacture, use or placing on the market (activity) of this substance is included in Annex XVII.

The supervised objects under REACH-Restrictions include substances, preparations and articles. The level of restriction can be divided into two main categories:

• Restrict the use or existence in certain products such as: the mass fraction of benzene should not exceed 5mg/kg in toys or toys parts; PBB cannot be used in textiles such as underwear, blankets, clothing and the skin contact items.
• Restrict all uses (ie, totally prohibited), such as asbestos, dichloro[(dichlorophenyl)methyl]methylbenzene, UGILEC121 Monomethyldibromodiphenyl-methane and so on.
  

Obligations of Importers:

REACH restrictions list covers a great deal of substances. Importers should urge manufacturers/suppliers to clearly understand the impact of REACH restriction on their products.

• Screen the REACH restriction list for the restriction most relevant to the products and ensure that the presence of restricted substances in products do not exceed threshold limits set by REACH;
• Some restricted substances are on the SVHC candidate list. Importers shall also comply with relevant requirements of SVHC under REACH.

Advice and Service

CIRS can carry out an assessment for you or your suppliers, in accordance with your specific industry and the relevant restriction list to determine which items do not need to be tested, thus improving the efficiency of your testing strategy and saving money on unnecessary testing. Finally, we can supply you with a series of tailor-made ’Assessment Reports ‘ to meet you various requirements.

CIRS offers RSL screening services and SVHC testing services in one package to you or your suppliers and make sure your products comply with the latest safety requirement of REACH. CIRS will inform you of the latest developments of REACH as a complementary service.