Sitmae issues Certificates of REACH Compliance. We distinguish between:

• Substances and mixtures
• Articles

For non-EU producers of Substances and Mixtures we act as their REACH Only Representative.
 
When we are your REACH Only Representative, your EU based customers receive a Certificate of REACH compliance every year. The certificate states that under REACH your customers are no longer ‘importers’ but simply ‘downstream users’, that all the registrations and pre-registrations have been taken care of, that we are your Only Representative and that we cover all your products. Inspectors are invited to contact us and to examine our records.

As your Only Representative, we take over all the REACH obligations from their European customers. We pre-register and register substances, we keep all the necessary records and in other ways ensure full REACH compliance. To your customers it will be, as if they had purchased your products from an EU-based supplier.
 
For more details on this subject see our dedicated webpage REACH Only Representative’.

REACH not only affects substances and mixtures, but also ‘Articles’.
 
Articles’ under REACH are objects with a special design or surface that is more important that their chemical composition.
 
Articles that are exported to the EU must also be REACH compliant. (Beware that packaging materials are nearly always ‘articles’).
 
Sitmae issues certificates of REACH compliance for articles.
 
But before we do, we first make sure that under REACH the product is indeed an article.
 
We check REACH compliance for every single ingredient of the article.
 
Based on our findings, we advise on restrictions to marketing and use, obligations to provide information, deadlines, substitution of ingredients and whatever else is needed to obtain REACH compliance.

• What is REACH compliance for articles?
 
• Testing for REACH compliance: not efficient and not necessary
 
• How we check for REACH compliance
 
• Substances, Mixtures or Article?
 
• REACH lists must constantly be monitored
 
• Can any product get a certificate of compliance?
 
Please note: This service is limited to articles of which the chemicals composition can be known and documented.
 
For more complicated articles see our dedicated web page ‘REACH Consultancy’.

In most cases the substances used in articles do not need REACH registration or pre-registration. But other REACH obligations exist. They depend on the substances in the article.
 
• For substances on the Candidate List of Substances of Very High Concern (SVHC), there are obligations to inform industrial customers and even consumers.
 
• For the same substances there is an obligation for REACH Notification to ECHA (European Chemicals Agency).

• ECHA may decide that some notified substances must undergo a REACH Registration.
 
• Some sixty different substances are subject to restrictions in marketing and use. The restrictions vary from not being allowed at all to not being allowed in fishing nets.
 
• An increasing number of substances are subject to Authorisation. After the ‘sun-set date’ they may only be used if a suitable permit has been granted.

If at all avoidable, we do not test the articles for the presence of certain substances. Testing for REACH compliance is far too expensive and cumbersome to be practical.
 
Also the REACH lists expand continuously.
 
By the end of 2012, there will be:
 
• Some 150 substances on the Candidate List.
 
• More then 60 substances subject to restrictions in marketing and use (REACH Annex XVII).
 
• At least 20 substances subject to authorisation (REACH Annex XIV).

Soon there will be more than 250 different substances that may cause a REACH restriction or a REACH obligation applying to articles.
 
As a result, testing for compliance will become far too complicated and overly expensive.
 
Also: a product fully tested today, may be non-compliant tomorrow.

For our Certificate of REACH compliance, we use detailed information supplied to us by the producer of the article.
 
The information that Sitmae needs:
 
• Trade names, pictures and intended use of the articles exported to the EU.
 
• All composing substances > 0,1% and an indication of their quantities
 
• Which REACH listed substances occur in which products.
 
• In some cases supplier statements of compliance may be acceptable.
 

This method is REACH approved, if the information is reliable and complete.
 
The checks by Sitmae consist of:
 
• We check if the products are indeed ‘articles’ under REACH and if the composing substances are therefore exempted from registration (Check against legislation and Technical Guidance Documents).
 
• We check for occurrence of the substances on the REACH Candidate List of Substances of Very High Concern.
 
• We check for occurrence of substances subject to Authorisation (Annex XIV REACH).
 
• We check for occurrence of substances subject to Restrictions to marketing and use. (Annex XVII REACH).
 
• Upon request, we can also check for occurrence of substances on non-official exclusion lists such as the SIN list (SIN: Substitute It Now!) and the Trade Union list.

Sometimes the distinction between substances, mixtures and articles is not very clear or obvious. Some examples: a thermometer containing a liquid is an article, but a pen is a container with a mixture. A battery is an article, but a candle is a mixture. Plastic pellets are a mixture, but plastic foil is an article.

To importers of these products, the distinction is very important! Substance and mixtures are subject to pre-registration and registration; articles are not. Almost all packaging materials are articles.
 
For more detail on this subject see our dedicated web page ‘REACH and Articles’.

All the REACH Lists are subject to change. On average twice a year substances are added. (So far not a single substance has been removed…). Monitoring these lists and the implications for REACH compliance is a continuous activity.
 
• At Sitmae we keep our lists perfectly up-to-date of course.

• We also look into the future: we monitor the official consultation processes for extensions of the lists.
 
• We keep track of the intentions of European Member State authorities and the European Commission with regard to substance specific restrictive measures.

REACH Certificate Value

Sitmae REACH Services is a limited company, not an official REACH authority. Our certificates are as good as our name.
 
We will only issue certificates if we are truly convinced that we have all the necessary information and that this information is correct.
 
To preserve our good name, we will only embark on a certification project when we are convinced that reliable information can indeed be obtained.

Some issues to consider:

• An article that is assembled from smaller articles (example: a beauty case or a television) is more difficult to certify than an article directly made from substances and mixtures. (example: O-rings and washers).
 
• A long the supply chain for the ingredients and components makes it difficult to get the correct information.
 
• Companies with an audited quality control system find it easier to supply the required information than those without.

• Where strict industrial standards (Example: automotive, aerospace, medicinal) are applied and audited, these may serve to simplify the certification procedure.
 
• Certification is a continuous process. Certificates have a limited time of validity. Changes in the REACH lists occur at any time, and so may the materials used for the production of the articles.
 

Suitable products

 
Some examples of products for which the REACH Certification service is typically suitable:
 
• Moulded plastic products.
 
• Tape (pressure sensitive or otherwise).
 
• Packaging materials like plastic bottles and metal drums.
 
• Plastic and rubber machine parts like washers and O-rings.
 
• Metal machines parts.
 
• Non-wovens.
 
More complex products may also be considered, but these need to be discussed in detail before any decision can be taken. See also our dedicated web page ‘REACH Consultancy’.