REACH Regulation (EC) No 1907/2006 – Article 7, Annex VII, and practical considerations for manufacturers – the CRASH COURSE

One possible cause for an audible “gulp” coming from the reader of a specifications sheet is coming across a requirement to comply, vaguely, with the REACH Regulation (EC) 1907/2006.

Broadly, REACH is meant to ensure that products in Europe do not contain dangerous substances. The law is mainly focused at the manufacturers of large amounts of chemicals, but if you are a manufacturer who has been presented with this requirement, here is a crash course about three highly important items to get started. This blog article will focus on those items and is not complete (the law is over 500 pages, including the amendments).

The first item to consider is Article 6 (1), see below –

Article 6 (1) is stating that if you make a ‘substance’ and send it to Europe in quantities over one ton then they must be registered with the EU, following the REACH requirements.

The substance can be by itself (picture barrels of chemicals) or in an article. An ‘article’ is what you make, and makes up what you make. In other words: a screw holding something together in your product is an article. The ‘substances’ referred to are the substances called out in the REACH Regulation.

However, as pertains Article 6(1) and all of REACH: the responsibility to comply is with the entity in the EU. US manufacturers have no legal responsibilities under REACH.

The second item to consider is Article 7(1), see below:

Considering the guidance presented above regarding Article 6(1), we understand this to mean that your customers in the EU are responsible to submit a registration to the Agency if the products (articles) they buy from you contains substances that are restricted by REACH are either in quantities over one ton or expected to be released in the environment. The ‘Agency’ referred to is the European Chemicals Agency.

The requirements must be handled in Europe by the importer, but a US manufacturer  should assist them in complying with the law by determining if chemicals listed in REACH are inside the product.

The third item is Annex XVII – Restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles.

Annex XVII lists substances that you cannot send in to Europe or can only send in after adhering to specific criteria. This brings me to the reason I decided to write this article, today. I received the weekly RAPEX report from the EU this morning.

I scrolled through it and came to this

Looking closely, we see the text –

 

 

Next, see the Reach regulation, Annex XVII (23) –

The Cadmium section goes on for four more pages, but see the second page –

This product contains 0.0676% in the plastic part of the lure, presumably that means the octopus eyeballs. The importer was forced to remove these items from the market and to warn customers of the risk.

These same restrictions apply to any equipment, it does not have to be a consumer good like a fishing lure.

F2 Labs is here to help.

Have a question or a comment? We can be contacted via this link. We can be reached by phone at 855-652-7281 and are here to help you.

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