REACH Regulation Services
Manufacturers and distributors of different sizes are increasingly facing substantial challenges resulting from globalization and newest international regulatory issues. With regard to companies having production, distribution or import of chemical substances, mixtures and articles containing chemicals and also for non-EU companies which have exports into the Europe, REACH Regulation significantly increases the complexity of regulatory compliance.
- REACH (Registration, Evaluation and Authorization of Chemicals) is the EU regulatory framework aiming to keep the hazards under control which arise from chemical substances within Europe. The REACH Regulation (EC) No.1907/2006 was published on the 18th of December, 2006 and sets out new regulatory obligations with the purpose of control of chemicals throughout the EU.
- Phase-in substances which have already been pre-registered prior to 1st of December, 2008 according to REACH Regulation can benefit from several registration deadlines. As a simple rule of thumb, starting from the highest tonnage threshold the registration deadlines is determined as: 2010, 2013 and 2018 respectively.
- Despite the fact that the pre-registrations under scope of REACH ended as of 1st of December, 2008; the regulation still offered to the companies which first manufacture and place their substances into the European market the opportunity to make their late pre-registrations for a certain tonnage threshold. According to Article 8 of REACH Regulation; a natural or legal person established outside the Community who manufactures a substance on its own, in mixtures or in articles, formulates a mixture or produces an article that is imported into the Community may by mutual agreement appoint a natural or legal person established in the Community to fulfill, as his only representative, the obligations on importers.
Cambridge Environmental Assessments (CEA)
C.E.A is a group company of ADAS UK LTD. which is a leading environmental solution and politics advisory service provider in the UK. Cambridge Environmental Assessments which was founded in Cambridge (UK) in the year 2000 is a company providing wide range consultancy services, combining chemical industry and experiences of public research centers with several EU and British chemical and environmental legislations which plays a key role from generation of related legislations to supporting the adaptation process. Especially its expert team working in the field of risk modelling and assessment has a leader position by legislation producers.
* In Japan, C.E.A. has a representative company which name is REPRE CO., Ltd.
WHAT CAN MY COMPANY DO?
Non-EU manufacturers should be aware of the registration requirements that any EU importers they work with faces and provide any support with them in order not to miss the pre-registration deadline. If registration is legally required, then they will be obliged to be ready with regard to any support to the registration by carrying out the hazard assessment/ Up-to-date SDSs in full compliance with EU classification provisions.
On the other hand, EU Manufacturers, importers or distributors should make their mind up about which substances they will have to register and when. They should also bear in mind the substitution alternative for most hazardous substances. And also Downstream Users in Europe should provide up-to-date information to their suppliers of their own use(s) and also consider substituting the most hazardous substances with less hazardous ones as far as possible.
WHAT EXACTLY MEAN LONG-TERM REGISTRATION DEADLINES?
A gradual registration deadlines scheme is already made available by Article 23 of REACH Regulation for phase-in substances. Such “grades” are constituted based on the tonnage thresholds and hazardous properties of chemical substances. The deadlines on which relevant registration dossier will be submitted to ECHA are as follows:
- 30th of November, 2010 for CMR 1 category substances ≥ 1 ton/ year, substances for which an R;50-53 hazard classification is assigned ≥ 100 tonnes/ year and any other substances with a tonnage threshold as ≥ 1000 tonnes/ year.
- 31st of May, 2013 for substances ≥ 100 tonnes/ year
- 31st of May, 2018 for substances ≥ 1 tonnes/ year
THE SCOPE OF PRE-REGISTRATION
Non-EU companies exporting phase in substances –on their own, in mixtures or in articles with intended release- into the EEA on or after December1, 2008 over 1 ton/ year, must assign an Only Representative, which acts as the EU Company importing the substances into the EU.
In such a case the deadlines mentioned below are obliged to be observed.
- within six months at the latest in case when the quantity of the substance subject to European export exceeds 1 ton per year, and before 12 months from the relevant registration deadline
INFORMATION TO BE SUBMITTED PRIOR TO PRE-REGISTRATION
• Substance identifiers such as IUPAC name, CAS and EC numbers
• Name and address information of potential registrant
• Contact details of the related person
• Predicted registration deadline
REGISTRATION PROCESS
Registration process for the companies involved, is much more complex and costly than pre-registration. Registration is a set of requirements for the industry which stipulates the collection and setting out information on the properties of the substances they manufacture or supply above 1 tonne per year. Such information will be used to perform an assessment on the hazards which may arise from the substance itself. Finally the information collected and drawn up will be submitted to the European Chemicals Agency (ECHA).
In line with the basic philosophy of REACH Regulation, REACH encourages the data sharing mechanism among registrants in order to minimize the animal tests and substantial costs. Its motto is: “One substance, one registration.”
OUR SERVICES WITH REGARD TO REGISTRATION
• Communication with SIEFs and Consortium;
• Preparation of submission/ joint submission dossier;
• Data gap analysis, literature search, GLP tests, QSAR ve read across method, submission of test proposals;
• Determination of data costs and LoA purchase;
• Individual dossier preparation via IUCLID 5 or;
• Preparation of complete IUCLID 5 registration including technical dossier and Chemical safety Report;
• Preparation and evaluation of SDSs&e-SDSs.
For further information concerning our services, please contact our experienced team.
**** 31 May was your last chance to submit a pre- registration for existing (phase-in) substances manufactured or imported at above one tonne per year. After that date, there is a registration obligation for substances imported more than 1 tonne per year to the EU.