Background to REACH
REACH is the abbreviation used for the EU regulation (REACH Chemicals Regulation 1907/2006) concerning the "'Registration, Evaluation, Authorisation and Restriction of Chemicals'. As a regulation, it applies to all EU member states as well as Norway, Iceland and Liechtenstein (but not Switzerland). The REACH regulation is administered by the European Chemicals Agency (ECHA) based in Helsinki.
REACH has the following impacts:
Every chemical made in or imported in the EU (plus Norway, Iceland and Liechtenstein) in a quantity over 1 tonne per annum (tpa) must be registered on the European Chemical Agency (ECHA) database. This includes not only pure chemicals but also formulated products and the monomers used to make polymers. Registration requires the submission of a dossier that describes the properties and hazards associated with the chemical's manufacture and use. The content of the dossier, the cost of the data that it includes, and the fee payable to ECHA depends on the company's size and the quantity that it intends to manufacture or import. There are reduced information requirements and fees for substances only used as intermediates, produced and used under strictly controlled conditions.
Only legal entities registered in the EU can register under REACH. Manufacturers including formulators based outside Europe may appoint an Only Representative to register on their behalf so that their importers having to register individually.
There are exemptions from the need to register for substances that are covered by other legislation (eg. biocides, radio-active materials). Exemptions are also possible for certain substances where sufficient information is available to show that they can be considered to present minimal risk.
ECHA will examine the dossiers to select substances for further evaluation under the Community Rolling Action Plan (CoRAP). As a result, some substances will be subject to restrictions on their use or there may be a requirement for companies to apply for authorisation to use them.
Substances of ‘Very High Concern’ (those classified as carcinogens, mutagens or toxic to reproduction category 1 (CMRs) under the Globally Harmonised System of Classification and Labelling (GHS) along with substances identified as persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)), will normally be subject to this authorisation process. This will require companies to demonstrate that they can be used safely and/or the socio-economic benefits outweigh the adverse risks from use. This includes demonstrating that it is not possible to substitute the substances with safer alternatives. Other substances with properties of ‘similar concern’, such as endocrine modifiers, can also be proposed as SVHC substances.
What Is Happening Now?
The phase in period to register substances finished at the end of May 2018. However, registration is not a single process. ECHA expect registrants to keep their dossiers up to date if there is new data. ECHA is continually imposing new requirements and an updated registration may require additional information to be added so that the dossier to pass the completion check.
The candidate list of substances of high concern that may be subject to authorisation is also growing. The list of substances proposed for inclusion is growing too.
The predicted departure of the UK from the EU (Brexit) will also impose new obligations on registrants.
What Happens Next?
ECHA has a rolling dossier checking programme. Check your REACH-IT inbox regularly for communications from ECHA.
New registrants must submit an inquiry dossier before they can register as a manufacturer or importer. This is required in order to identify the Lead Registrant who will provide a Letter of Access to the technical dossier. It also enables the new registrant to confirm that its substance is covered by the dossier. It is normally possible to identify the Lead Registrant by other methods but the absence of an Inquiry reference number can delay the purchase of the dossier or require the registration to include an explanation for its absence.
Alemare Solutions can help in this process by advising which information is required. We can also provide a dossier authoring and submission
service for registrants who are not familiar with the process.
To find out more about REACH Regulations and our services, get in touch today.