REACH Registration

REACH Registration

REACH Registration is the core of REACH Compliance. The REACH Registration deadlines for existing chemicals depend on volume and toxicity, For existing substances Pre-registration is necessary.   New substances cannot be pre-registered, but must be registered immediately.   Learn more:   • Reach Registration at a glance   • Registration deadlines

Reach registration at a glance

Almost every chemical marketed in the EU in a quantity over 1 ton per year will have to be registered under REACH.   REACH Registration involves submitting a vast technical dossier with toxicological and eco-toxicological information, a risk assessment, recommendations on how to manage the identified risks, proposals for classification and labelling etc. The REACH Registration dossier must often include a ‘Chemical Safety Report’ (CSR) and ‘Guidance to Safe Use’.   Only European legal entities can register: European chemical manufacturers, European importers and the ‘Only Representatives’ for non-European chemical manufacturers or formulators.
New substances must be registered immediately.   ‘Phase in’ (i.e. existing) substances may be registered spread out over time. The timing depends on the volume and toxicity.   To be able to use the time delays, existing substances must be pre-registered.   Sitmae offers a registration service. See our dedicated web-page REACH Registration.

REACH Registration deadlines

Under REACH, all new substances must be registered immediately.   • CMR ≥ 1 t/y (Carcinogenic, Mutagenic, Reprotoxic Cat. 1 & 2. EU Risk phrases R45, R40, T/R46, R60, R61, T/R60 and T/R61)   • Other substances ≥ 100 t/y   • Other substances ≥ 1 t/y
Small volume Existing substances enjoy time delays.   Immediately       Immediately   31 May 2018

Scope and exemptions

Most chemicals are in scope of REACH. The lower threshold is 1 tonne per year.   Important exemptions exist. Confusion about the REACH exemption of polymers is notorious. The monomers used to produce the polymers must be registered.   Under REACH ‘Articles’ (objects) have their own rules.
See also our dedicated web-pages:   • REACH Scope & exemptions   • REACH and Articles

Intermediates

Under REACH, intermediates are substances that only used in a further chemical reaction to make another substance.   REACH distinguishes:   • Non-isolated intermediates: Substances that occur during the manufacturing process but are not intentionally removed from that process.   • Isolated intermediates: Substances that are removed from the process and are stored to await further processing.   • Transported isolated intermediates: Intermediates that are transported between sites.
For exact definitions see our dedicated web page: ‘Glossary and Acronyms’.   REACH Registration for intermediates is easier than for other substances.   This does however not apply to monomers that are used to make polymers.   Substances registered as intermediates may only be used under ‘strictly controlled conditions’ (SCC). In the registration dossier, proof must be provided.   For details, see the official ‘Guidance for Intermediates’, downloadable from the ECHA web site.

Non-EU REACH Registrations

REACH Registrations in a non-EU supply chain   Non-EU formulators (producers of ‘mixtures’) may be able to purchase substances that have already been REACH registered by a non-EU supplier.   These substances do not need to be registered again.   Proof of registration and traceability are required.
REACH Re-importation scheme   Non-EU formulators (producers of ‘mixtures’) may buy substances that were REACH registered by their European Manufacturer.   Where this is the case, the importer or the non-EU formulator’s Only representative no longer need to register the substances.   Proof of registration and traceability are required.

How REACH registration works

The consortium   The complex REACH registration dossiers are generally prepared by a consortium. A consortium is generally a group of manufacturers and importers of the same substance.   They determine the ‘substance ID’, which gives the specifications of the substance for which the dossier is produced. This includes for instance bandwidths for all possible impurities.   They share toxicological studies already in their possession and commission additional studies if necessary.   Lead registrant   One of the cooperating companies is the first to register under REACH; this is the ‘Lead registrant’. The Lead Registrant is the only one to actually submit the complete dossier.   Other registrants   Other registrants submit only the individual part of the registration dossier. This part includes analytical proof that their substance answers to the ‘substance ID’, Quantities imported or manufactured
Letter of Access   Companies that do not actively participate in the consortium can purchase a ‘Letter of Access’ (LoA). The cost for these LoA’s is equal to a fair share of the total costs.   Submission to ECHA   Once complete, the registration is submitted to ECHA (European Chemicals Agency). Here the submission is automatically checked for completeness. If it passes the automatic checks, ECHA sends its invoice.   Paying the ECHA invoice   The ECHA invoice depends on the size of the company and the tonnage band. Once the ECHA invoice has been paid, the registration number is sent out, and the registration is complete.   • For cost information see below the section on ‘REACH Registration costs’.

REACH Registration costs

This section only refers to a ‘Joint Submission of a REACH dossier’. This means that the REACH Registration dossier was prepared by a consortium.   The REACH Registration costs consist of:   • Cost of the Letter of Access to the joint submission of the dossier.   • ECHA fee.   • Fee for Only Representative or Service provider.   Cost of the Letter of Access (LoA)   The costs of the REACH registration dossier and the management of the consortium are high. For large volume substances (i.e. > 1.000 t/a), these may vary between € 0,5 and € 3 million!   Most consortia are meticulous about a fair pricing of the LoA. If not; they are in breach of EU competition law.   LoA’s vary very much in price, since they depend on the number of registrants. For substances > 1.000 t/a, an expensive LoA may cost over € 100.000 and a cheap one may cost € 10.000.
ECHA Fee   The ECHA fees vary widely and depend on the volume band of the substance and the size of the company.   Large companies (employing > 250) registering > 1.000 t/a will pay € 24.901,- .   ‘Micro’ enterprises (employing less than 10) registering 1 – 10 t/a pay only € 64.   The criteria include headcount, turnover, balance sheet total and whether the company is ‘autonomous’. If a company claims to be an SME (Small or Medium sized enterprise);, it must be able to provide proof. Several years of annual accounts are necessary. ‘Mistakes’ are seriously fined.   To download ECHA fees regulation or guidance on the SME criteria go to our dedicated web page 'Glossary and Official Texts'.   Fee for Only Representative or Service provider   Even if the dossier has been prepared by a consortium, REACH Registration is still complex and time consuming.   The Only Representative or Service provider will charge a fee. This fee may depend on the complexity of the case.

REACH and Recovered substances

When a substance is recovered from a waste stream in the EU, it does need not be registered under REACH again.   The substance must have been registered by someone else and the necessary information (i.e. an Extended Safety Data Sheet) must be available.  
The exemption (no need to register recovered substances) only applies to recovery taking place in the EU. Recovered substances imported from outside the EU must under REACH be registered as if they were virgin material. On the other hand: if the recovered substance is still ‘waste’ when it is imported, it needs not to be registered.

REACH and Toll manufacturing

Sometimes the actual manufacture of a substance is jobbed out to others; the so called ‘toll manufacturers’.   It is not well regulated who should register the substance under REACH ; the principal or the toll manufacturer.   As default, it is the toll manufacturer that should register the substance.
It is however allowed for the principal and the toll manufacturer ‘to make practical arrangements to reduce the burden for the toll manufacturer’. Often the principal registers the substance in the name of the toll manufacturer, under the agreement that the Principal may transfer the registration to another producer when necessary.

Alloys and intermetallic compounds

According to REACH, alloys are ‘special mixtures’. They must be treated in the same way as other mixtures.   Therefore the alloy as such is not subject to REACH registration, but each of the alloying metals are.   Components that are not important for the properties of the alloy are considered ‘impurities’ and don’t need to be registered.
‘Intermetallic compounds’ are different from alloys. They have a well defined stoichiometry.   These intermetallic compounds have their own EINECS numbers, such as ‘aluminium, compound with iron (1:1)’ or ‘iron, compound with titanium (2:1)’. Under REACH they must be registered as a single substance.

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