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REACH

Registration, Evaluation, Authorization and Restriction of Chemicals

REACH is a European Community (EC) safety regulation that deals with the registration, evaluation, authorization and restriction of chemical substances. Effective from 1 June 2007, REACH requires that manufacturers and importers register all substances they produce in and/or import to the EU in quantities ≥ 1 ton per year with the Helsinki-based European Chemicals Agency (ECHA).

As a European Union (EU) regulation, REACH fully applies to all member states.

REACH compliance poses a big challenge for most companies. It is a complex set of regulations that require extensive and specific technical competence and knowledge. As your experienced partner, TÜV Rheinland offers professional REACH services for the efficient REACH registration of your product´s chemical substances. We can assist you at each stage, providing consultancy and testing for manufacturers, distributors, and importers on all requirements for successful REACH registration.

We offer REACH services in cooperation with Luxcontrol , our REACH accreditation partner.

Benefits at a Glance

With TÜV Rheinland’s professional REACH services, you can:

  • Secure access to the European market by ensuring the mandatory registration of your product´s chemical substances.
  • Rely on our qualified and trusted REACH registration experts.
  • Achieve REACH compliance cost-effectively and steadily.
  • Minimize your risk of liability with documented safety standards.
  • Boost confidence in the quality of your products and services.
  • Use your financial and human resources more efficiently.
  • Benefit from TÜV Rheinland´s one-stop-shop services.

Our REACH Services

REACH services prior to registration

  • REACH consultation and advisory services
  • Analysis of REACH involvement
  • REACH project plan
  • Risk analysis, including risks of SVHC substances
  • Conformity evaluation
  • Substance inventory
  • Data gap and cost analysis
  • Preparation for REACH registration

REACH pre-registration services

  • Company representation during pre-registration
  • Pre-registration of all substances

Consortia management services

  • Guidance through Substance Information Exchange Forum (SIEF)
  • Preparing consortia formation
  • Representing companies in consortia
  • Checking your consortia contracts
  • Checking the cost sharing model of your consortia membership
  • Checking the validity and nominal value of shared study reports

REACH registration services

  • Representing your company during registration while guaranteeing your anonymity
  • Laboratory support (for testing, toxicology, planning and execution of studies)
  • Compilation of technical dossiers (IUCLID 5)
  • Compilation of CSA/CSR (Chemical Safety Report)
  • Support for the authorization procedure
  • Complete “only representative” services for non-EU manufacturers
  • Registration of new substances
  • Communication with the ECHA

REACH authorization services

  • Identification of substitution alternatives for your substances
  • Implementation of risk management measures (hazard control)
  • Verifying the physicochemical and toxicological data of the relevant chemicals in your products
  • Socio-economic analysis

REACH testing services

  • Development and application of test strategies
  • SVHC testing and notification
  • Screening tests for CMR Categories 1 and 2
  • Chemical analysis specific to the material type and function
  • Filtering the substances and laboratory strategies

REACH compliance services

  • Development and update of safety data sheets with product assessment data
  • Evaluation of studies
  • Support for the CLP regulation on classification & labeling
  • General project support
  • REACH training workshop

Registration, Evaluation, Authorization and Restriction of Chemicals

REACH stands for: the Registration, Evaluation, Authorization and Restriction of Chemicals

Registration

Manufacturers or importers who manufacture and/or import substance(s) to the European Union (EU) in quantities of one ton or more per year OR import articles with substance(s) intended to be released in quantities of one ton or more per year must register those substance(s) with the European Chemicals Agency (ECHA) by submitting a technical dossier detailing all physicochemical and toxicological properties of the chemicals involved and the safety measures required in handling them.

For substances contained in products that are imported or manufactured in quantities of more than 10 tons per year, a Chemical Safety Report (CSR) including exposure scenarios is also required for successful REACH registration.

Evaluation

The ECHA will review all REACH registration documents and may request additional information if deemed necessary.

Notification

Producers or importers of articles may need to notify the ECHA if there is any SVHC in said articles above a concentration of 0.1% by weight.

Authorization

ECHA authorization is required for Substances of Very High Concern (SVHC). The list of substances subject to authorization includes those that fall into the following categories.

  • CMR − Carcinogenic, Mutagenic or Toxic to Reproduction
  • PBT − Persistent, Bioaccumulative Toxic
  • vPvB − Very Persistent and Very Bioaccumulative
  • Substances of equivalent concern with scientific evidence of probable serious effects

Authorization may be granted if there are no suitable alternative substances or technologies available and if the social and economic benefits outweigh the risks.

Restrictions

EU member states may propose restrictions on the manufacturing, marketing and use of certain dangerous substances and preparations. These may be subject to EC-wide restrictions if their use poses unacceptable risks to health or the environment (Annex XVII REACH).

REACH SVHC List

The SVHC candidate list, which is part of EU REACH regulation, currently contains 144 chemical substances. The ECHA will later determine whether these substances should be added to the authorization list, which contains 22 SVHCs at present. All manufacturers, importers and retailers involved in EU markets are advised to ensure that their products are free from these SVHCs in order to avoid possible penalties and product recalls.

Examples of Products Subject to REACH Registration

If you are a manufacturer or importer of one or more of the products listed below, you must complete REACH registration procedure prior to obtaining legal access to the EU market.

  • Alloys and plastics
  • Chemicals
  • Oil, fuel and gas
  • Semi-final products such as plates, pipes, tubes, castings
  • Toys
  • Furniture
  • Cosmetics, accessories
  • Stationery
  • Pigments, paints, glues
  • Detergents
  • Textiles, footwear, leather
  • Electronic and electrical products

and more …

Role of the Companies in the Supply Chain Regarding REACH

Manufacturer

  • Duty of REACH registration
  • Duty of communication
  • Communication of safe use
  • Duty to communicate information to customer
  • If necessary: REACH authorization

Importer

  • Duty of REACH registration
  • Duty of communication
  • Communication of safe use
  • If necessary: REACH authorization
  • Notification (SVHC in articles)
  • Duty of information (SVHC in articles)

Downstream user

  • Communication of usage
  • Application of information from MSDS
  • Preparation of chemical safety report for special uses

Distributor

  • Duty to communicate information down the supply chain
  • Transfer to safety data sheets respective of information for safe use (downstream)
  • Transfer of use conditions (upstream)

Scope of REACH Registration

  • Chemical substances (single elements and their compounds)
  • Preparations (mixture of substances including alloys and plastics)
  • Articles (special shapes or designs that function to a greater degree than their chemical compositions)

SVHC Candidate List 2013

A substance of very high concern (SVHC) is a chemical substance (or part of a group of chemical substances) for which it has been proposed that the use within the European Union be subject to authorization under the REACH Regulation. There are 144 substances on SVHC candidate list (PDF, 229 KB) and 22 substances on SVHC authorization list (PDF, 113 KB) (updated in July 2013).

See more (PDF, 179 KB)