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REACH services by TUV Rheinland

Registration, Evaluation, Authorization and Restriction of Chemicals

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

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

REACH compliance poses a big challenge for most companies. It is a complex set of regulation that require extensive specific technical competence and knowledge. As your experienced partner, TÜV Rheinland offers professional REACH services for the efficient REACH compliance of your product. We assist you at every stage including 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 Competence Centre.

Scope of REACH Regulation

  • 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)

REACH

Registration

Manufacturers or importers who manufacture and/or import substance(s) to the European Union (EU) /European Economic Area (EEA) 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.

REACH Candidate List

The Substances of Very High Concern (SVHC) candidate list, which is part of EU REACH regulation, currently contains 211 chemical substances.

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The substances on candidate list includes those that fall into the following categories.

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

The ECHA will later determine whether these substances should be added to the authorization list. All manufacturers, importers and retailers involved in EU markets are advised to ensure that the SVHC in their products is within a concentration of 0.1% by weight in order to avoid possible penalties and product recalls.

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 listed in Annex XIV of REACH Regulation. 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).

SCIP Database

SCIP is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD). As from 5 January 2021, companies supplying articles containing SVHCs in a concentration above 0.1% by weight on the EU market have to submit information on these articles to ECHA. The SCIP database ensures that the information on articles containing Candidate List substances is available throughout the whole lifecycle of products and materials, including at the waste stage.

Benefits of our REACH Compliance Services 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 and testing of articles for SVHC compliance
  • Rely on our qualified and trusted REACH experts
  • Achieve REACH compliance cost-effectively and steadily
  • Boost confidence in the quality of your products and services
  • Benefit from TÜV Rheinland´s one-stop-shop services

Our REACH Services

We provide a single-source solution for complying with the registration, testing, and documentation requirements of the European Union's complex REACH Regulation.

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REACH Services Prior to Registration

  • REACH Consultation and Advisory Services
  • Analysis as per REACH Substance Information Profile (SIP)
  • Conformity Evaluation
  • Substance Inventory
  • Data Gap and Cost Analysis

Consortia management services

Guidance through Substance Information Exchange Forum (SIEF)

Preparing consortia formation, representing companies in consortia

Checking consortia contracts & the cost sharing model of consortia membership

Checking the validity and nominal value of shared study reports

REACH Registration Services

Representing your company as Only Representative while guaranteeing your anonymity

Laboratory support (for testing, toxicology, planning and execution of studies)

  • Compilation of technical dossiers (IUCLID 6) and CSA/CSR (Chemical Safety Report)
  • Support for the authorization procedure
  • 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
  • Analytical testing of SVHC substances
  • Screening tests for CMR Categories 1 and 2
  • Filtering the substances and laboratory strategies

REACH Compliance Services

  • Development and update of safety data sheets with product assessment data
  • Support for the CLP regulation on classification & labelling
  • REACH training workshop

REACH Regulation Update:

REACH SVHC list is dynamic and is updated twice a year. On 19th January 2021, European Chemicals Agency (ECHA) has updated the Candidate List and included two chemicals that are toxic for reproduction. The two substances are used in products, such as inks or toners and to produce plastics and rubber tyres. This recent update has been made in line/ continuation with its objective to protect human health as well as the environment from the risks posed by chemicals.

REACH Candidate List

pdf 211 Substances of High Concern (SVHC) 301 KB Download