REACH and Articles

REACH and Articles

Under REACH, ‘Articles’ are objects with a special design. They are not ‘Substances’ or ‘Mixtures’ and have their own obligations.
 
REACH Restrictions may apply.
When Articles contain Candidate List Substances, communication with customers is required and REACH Notification to ECHA may be needed.
 
Authorised substances may, in the EU, rarely be used to produce articles

REACH and articles at a glance

Substances in ‘Articles’ are not subject to REACH Registration or Pre-Registration.
 
The articles are however regulated by REACH in different ways.
 
It is not always obvious if, under REACH, a product qualifies as an ‘article’. Some objects that seem to be articles are regarded as ‘mixtures’ or as a ‘mixture in a sophisticated container’.
 
If an article has an ‘Intended Release’, the released substance is subject to REACH registration.
 
Annex XVII lists Restrictions to ‘Marketing and Use’. A considerable number of substances are prohibited in certain groups of articles.
 
If an article contains substances from the Candidate List of SVHC, the users must be told.
 
In the EU, articles may not be produced using authorised substances, unless an exemption or permit applies.
 
NGO’s and Trade unions have produced lists of substances that in their opinion should be substituted.

Article or Mixture?

No testing required
 
Testing articles for REACH compliance is not the preferred method.
 
ECHA recommends: “obtaining the necessary information by pro-active request in the supply chain” as the most appropriate method to check compliance of articles with REACH.
 
Examples:
 
The official Technical Guidance Document on Requirements for Substances in Articles (v2, April 2012) states explicitly (§ 5.2):
“Although chemical analyses may be helpful in certain situations, it is to be noted that they may yield ambiguous results and/or be very costly and are thus not recommended as the preferred instrument for obtaining information.”

Articles with an Intended Release

Under REACH, ‘Articles with an Intended Release’:
 
a) release substances during their use and
 
b) this release is intended as part of the main function of the article or to provide a desired other effect.
 
Examples: labels giving off a scent and some kinds of active packaging materials.
 
Many releases are not considered ‘intended’. For example: the loss of colour when washing clothes is not an intended release.
Most articles that ‘release’ a substance or a mixture fall in the category of ‘mixtures in a sophisticated container’ or ‘mixtures on a carrier material’.
 
The substances that are intentionally released are subject to REACH registration and pre-registration.
 
See also the section on Article or Mixture.

REACH Annex XVII: Restrictions to Marketing and Use

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)
 

Candidate List substances and Information requirements

When articles contain Candidate List substances (>0,1%), the supplier of the article must provide the ‘Recipient’ with the name of the relevant substance and enough information to allow safe use.
 
‘Recipients’ are industrial or professional users and distributors. Consumers are not ‘Recipients’.
Consumers must receive the same information upon request; within 45 days and free of charge.
 
In the case of imported articles, the REACH obligation to provide information lies with the importer when he places the article on the market.

REACH Notification to ECHA

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.

Articles and Authorised substances

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.
Please note:
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.

ECHA may require REACH registration

ECHA may require EU producers or importers of articles to submit a REACH registration for certain substances in the articles.
 
This is possible if:
 
• The quantity of the substance exceeds 1 tonne per year, and
 
• The substance is released from the article. (Not necessarily an ‘intended release’), and
 
• The release presents a risk to humans or the environment.
It is not known if and when ECHA will make use of this possibility.
 
ECHA will use the REACH Notification of Candidate List Substances in articles to determine if there is a need for Registration.

The 0,1% rule

For the REACH Candidate list obligations regarding articles, the cut of point is a concentration limit of 0,1%.
 
The question arises: ‘What is the article; the whole Korean car or every single tyre?’
 
The European Commission’s legal interpretation of REACH is ‘the whole Korean car’.
Seven Member States however, amongst which Germany and France, disagree: they argue that every nut and bolt is a separate article.
 
It is possible that this issue will be decided in the European Court in Luxembourg.

SIN list and Trade Union List

A number of NGO’s, in cooperation with some large producers of consumer goods, wish the REACH Candidate List to be much longer than it is at present.
 
They have proposed their own list. The NGO’s SIN list: ‘Substitute It Now’ addresses mainly substance that should in their opinion not be present in consumer products.
The European Trade Union have also produced such a list. Their list focuses on chemicals that should be banned from the workplace.
 
These lists have no legal implications. Politically they have the effect of pushing the European Commission and the Member States towards a rapid expansion of the Candidate List.

REACH Certificates for articles

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.


User Rating: 4.7 (14 votes)
Sending