Every company in Europe that produces, imports, distributes and/or uses chemical substances as such, in mixtures and/or in articles has to deal with REACH & CLP. A company would be wise to take a good look at its business case and product portfolio in order to understand and secure the relevant obligations from REACH & CLP in an efficient chemical management approach within the organisation.
If an EU company produces substances (manufacturer) or imports substances on their own or in mixtures into the EU (importer), in a total volume of more than 1 tonne per year, it must fulfil the registration obligations for that substance(s) as a company under REACH. The registration must be completed before the substance is manufactured or imported. No registration means no market (no business).
Classification and labeling
If an EU company produces mixtures (downstream user), it may only use substances and mixtures that comply with REACH and is responsible for the correct classification and labelling of the mixture in accordance with CLP.
Safety Data Sheets
If an EU company that produces or imports substances or mixtures and also places them on the EU market (supplier), it must produce a Safety Data Sheet (SDS) in accordance with REACH & CLP. A SDS must be made for hazardous substances and mixtures (at least one H-phrase on the label). On request, a SDS can be made for non-hazardous mixtures that contain hazardous substances. The supplier may also decide to make a SDS for non-hazardous substances and mixtures. The supplier must deliver the SDS to the EU customers of his product in the language of receipt upon the first delivery and in case of relevant changes to the SDS.
If a non-EU company produces substances or mixtures, it has nothing to do with REACH & CLP. His EU customers are then by definition an importer and must ensure that they comply with the REACH & CLP obligations. However, the Non-EU company can appoint an “only representative” in the EU in accordance with REACH, to take care of the importer obligations of the EU customers of the Non-EU supplier. If this is done properly and passed on to the EU customers, the EU customers are not an importer, but a downstream user. This means that it does not matter for an EU customer whether he buys the product from an EU or non-EU supplier (fair trade).
If an EU company procures and resells substances and mixtures without doing anything with them (distributor), he is responsible for assessing whether the supplier SDS complies with REACH & CLP and must keep the supplier SDS up to date. When delivering to EU customers, he has to supply or convert the right supplier SDS to his own SDS. Finally, his main responsibility is to pass on relevant use, product and SDS information back and forth to and from the supplier(s) and customer(s). As soon as an EU company does operations with the products, such as repackaging or blending, he is not a distributor but a downstream user.
If an EU company uses (hazardous) substances or mixtures (downstream user), he therefore receives a SDS from the supplier, and he must assess its compliance with REACH & CLP. If it concerns a extended SDS with exposure scenarios, the downstream user must carry out and document a use compliance check within 12 months. In this check, he assesses whether his uses are covered by an exposure scenario and whether his activities are safe according to the relevant exposure scenario(s). If there are problems with the use compliance check, the downstream user can contact his supplier to resolve them. If the downstream user cannot complete the use compliance check in 12 months, he should in principle no longer use the product.
Dealing with substances of very high concern
All EU companies that manufacture, import, distribute and/or use substances or mixtures, must consider the substance of very high concern (SVHC) and the conditions imposed on such SVHC substances. This certainly applies if the substance is on the Authorisation or Restriction List.
If an EU company makes or imports a product whose shape, design or structure is more important for its function than its chemical composition, it is a manufacturer or importer of an article. If an article contains a substance that is intended to be released, such as, for example, a t-shirt or a toy containing a fragrant substance, the manufacturer or importer has a registration obligation for that substance. However, his main responsibility under REACH, is to identify any SVHC in concentrations greater than 0.1% (w/w) in the article and pass it on to ECHA and the recipients of the articles. As a supplier of articles, he does not have to carry out a hazard classification according to CLP or prepare and supply a safety data sheet. However, he can decide to provide safe use instructions for the article.
Impact on companies