The EU Chemicals Regulation
The reform of chemicals legislation in the European Union was intended to create a standardized set of regulations for all EU member states. The Chemicals Regulation REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) came into effect on June 1, 2007.
Evonik supports the REACH Regulation’s aim of improving protection of health and the environment in the handling of chemicals, and consistently implements the Regulation.
The last registration phase, for chemical substances between 1 und 100 metric tons p.a., is currently running and ends on May 31, 2018. It applies to all chemical substances which are produced, imported or place on the market in the EU.
For more information see Registration periods.
Registration periods and deadlines:
Preregistration: June 1, 2008—December 1, 2008
Substances ≥ 1,000 metric tons p.a. , CMR ≥ 1 metric ton p.a., R50/R53 ≥ 100 metric tons p.a. by November 30, 2010
Substances 100 – 1,000 metric tons pl.a. by May 31, 2013
Substances 1 – 100 metric tons p.a. through May 31, 2018
In 2008, Evonik successfully completed 13,600 pre-registrations for 4,000 substances.
By November 30, 2010:
At the beginning of 2009, Evonik became the first company in the market to successfully register synthetic amorphous silica, in other words, precipitated silica (including ULTRASIL® and SIPERNAT®) and fumed silica (AEROSIL®). The substances were registered through a joint submission on behalf of the relevant REACH consortia.
By the end of the first registration period (November 30, 2010) for large-volume chemicals (> 1,000 metric tons p.a.), Evonik had successfully registered almost 170 substances with the European Chemicals Agency (ECHA).
May 31, 2013:
Evonik had successfully submitted over 660 registration dossiers for more than 460 substances by this date.
May 31, 2018:
The third registration phase, which ends on May 31, 2018, is for the 1-100 metric tons p.a. band. Evonik has already successfully submitted around 900 registration dossiers for more than 620 substances.
For a specialty chemicals company like Evonik, implementing the complex requirements of the REACH Regulation involves performing a whole range of tasks to ensure that our products comply with the law. This can only be achieved with appropriately trained staff, suitable IT systems, considerable financial outlay, and active involvement in trade associations. For this reason, Evonik is an active member of the corresponding working groups and committees of the German Chemical Industry Association (VCI), the Federation of German Industry (BDI), the European Chemical Industry Council (Cefic), and other organizations such as the Technical Committee of Petroleum Additive Manufacturers in Europe (ATC) and the European Silicones Center (CES).
Communication within the value chain is also very important for us. We have therefore set up a single point of contact for all REACH-related questions from customers and suppliers on specific products and substances.
Evaluation is becoming an increasingly important aspect with regard to REACH. REACH defines three different types of evaluation:
Examination of testing proposals (Annexes IX and X)
The ECHA checks that the testing proposals submitted by registrants are appropriate and justified. One aim of this evaluation is to avoid unnecessary tests on animals. Under REACH Article 40 (3), the ECHA decides whether to accept, reject or require modification of testing proposals.
Dossier evaluation (compliance check)
Under REACH, the ECHA is required to perform compliance checks on at least 5% of the dossiers to ensure they meet the requirements. That includes checking that the information provided complies with the requirements and that there is adequate justification for deviations from standard information. In addition, it includes requesting further information in accordance with article 41 (3). “Targeted compliance checks” are additional checks where the ECHA only looks at a certain part of the registration dossier (e.g. specific end-points).
Substance evaluation is performed by the relevant authorities in the member states. The Community rolling action plan (CoRAP) lists substances that have to be evaluated during a three-year period. The authorities check companies’ registrations and chemical safety assessments. Article 46 specifies that the competent authorities can require further evaluations.
Evonik has more than 30 substances affected by the substance evaluation process.
Apart from registration, which is the legal precondition for producing and importing substances and placing them on the market, and the complex communication process within the supply chain, further significant aspects are authorization and restriction. While restriction was used as a regulatory method even before the introduction of REACH, the authorization procedure is new.
Evonik is aware of the importance of these aspects and continuously screens its portfolio against substances that are intended for inclusion in the registry of intention, already included in this registry, or included in Annex XIV (Authorization List) to ensure timely identification of any that are affected.
If this is the case, Evonik checks which are the most appropriate measures. These may be, for example, an authorization application, substitution if this seems possible, or a decision to drop the substance and its applications in the future. In parallel with this, the next steps are clarified in close consultation with our customers.
For a company like Evonik, it is essential to ensure timely involvement of those affected, consider alternatives to the authorization procedure, and take account of steps already being taken in accordance with specific EU rules.
In addition, Evonik is committed to ensuring that performance of the risk management options analysis (RMOA) is uniform and where possible mandatory in all EU member states.
In addition, a ruling on small quantities is desirable to simplify the authorization procedure and reduce fees.
Evonik is of the opinion that the evaluation periods for authorization should be aligned appropriately to investment cycles and should not exceed 12 years.
At present, Evonik is not directly affected by any authorization procedures. In many cases, a specific restriction on use of the substance rather instead of mandatory authorization can greatly reduce the negative economic impact and, at the same time, enhance efficiency and provide a reliable legal basis.
Further information on REACH can be found on the European Chemicals Agency website.