The official title of REACH Annex XVII is ‘Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles’.
Many of the entries were already in force before REACH came into force. ‘No cadmium in paint’ has been an EU rule for many years.
The restrictions are many and varied. Some sixty entries regulate anything from baby clothes to fishing nets.
REACH Annex XVII is regularly expanded.
This annex may in the future be used to regulate imported articles containing authorised substances. (In the EU, articles may not be produced using REACH authorised substances, unless an exemption or permit applies. The same articles may however be imported into the EU)
Producers and importers of articles that contain Candidate List substances must notify ECHA.
As a general rule, REACH notification is necessary if:
a) the total amount of the Candidate list substance is more than 1 tonne per year per article group and
b) the concentration in the article exceeds 0,1%
Notification is however not necessary if:
a) Exposure to humans and the environment (including the waste stage) can be excluded or
b) The substance in question has been already been REACH registered for that particular use.
In both cases the decision should be documented.
The ‘REACH Registration of the substance for that particular use’, need not necessarily be done by the producer or the importer of the article or even the supplier of the substance. Any REACH registration of the substance counts.
Under REACH, articles may not be produced in the EU, using authorised substances, unless an exemption or a permit applies.
Imported articles may contain authorised substances.
All articles, including imported articles, are however subject to Annex XVII (Restrictions to Marketing and Use). This annex may be used to prohibit the import of articles with certain authorised substances.
Authorised substances still feature on the REACH Candidate List.
This means that the REACH obligation to provide information to recipients and consumers also applies to these authorised substances.
Also the obligation to notify ECHA remains in place.
Importers of articles wish to be sure that these are REACH compliant. They may even demand ‘REACH certificates’.
This often leads to an uncontrolled and expensive testing of the products for Candidate List substances. Products are tested for even the most unlikely ingredients.
The tests become worthless as soon as the REACH Candidate List is expanded again or the product changes.
The enforcement authorities do not necessarily demand test results. Other methods of proving REACH compliance are also acceptable. Declarations by reliable suppliers are seen as a good alternative; “obtaining the necessary information by pro-active request in the supply chain” is an officially recommended method.
Sitmae offers an REACH Article Compliance method: simple and effective. See our dedicated web page.