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.
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.
- Rely on our qualified and trusted REACH registration experts.
- Achieve REACH compliance cost-effectively and steadily.
- 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
- 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
- Evaluation of studies
- Support for the CLP regulation on classification & labeling
- General project support
- REACH training workshop
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
- Manufacturing additives and 3D printing material
- Pigments, paints, glues
- Detergents
- Textiles, footwear, leather
- Electronic and electrical products
- and more …
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 235 chemical substances. 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 their products are free from these SVHCs in order to avoid possible penalties and product recalls.
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)
PFAS testing: Prepare now for legal changes
The PFAS (per- and polyfluoroalkyl substances) group of chemicals is currently attracting particular attention in international markets. These chemicals have been detected at high levels in the environment. They are also harmful to the environment, hazardous to health and very persistent.
In the US market, some states have already introduced restrictions on the use of PFAS in clothing or food packaging. In January 2023, five national EU authorities submitted a proposal to restrict PFAS in the EU. On February 7, 2023, ECHA published the report on the proposed Annex XV restrictions, which in its current form would represent one of the largest bans on chemicals in Europe.
Respond to the issue now! You can safeguard your products with a chemical analysis. As an experienced testing and certification body, we have been dealing with the internationally applicable critical values for a wide range of chemical groups for years. We offer you three different test packages to determine if the proposed restrictions would affect your product:
- Test package 1 Existing restrictions for the EU market (incl. Switzerland).
- Test package 2: as package 1 and additional PFAS (C4F to C16F, > 25 PFAS)
- Test package 3: Total Fluorine (TF)
- Test package 4: Total Organic Fluorine (TOF)
Take the first step to be able to replace PFAS-containing components in a feasible way. With an analysis and monitoring of your supply chains, you can also remove PFAS from your production. We are happy to support you with our on-site audits.
References
| Reference Case: European-Plastic-Joint-Stock, Vietnam | 101 KB | Download |
Our Sustainability Initiatives
Nothing less than the future is at stake. Companies, institutions, public authorities and each and every one of us can play a positive role in shaping the path to tomorrow. We provide you with comprehensive support to ensure that you operate safely, sustainably and efficiently for many years to come.
Our Sustainability Initiatives
Nothing less than the future is at stake. Companies, institutions, public authorities and each and every one of us can play a positive role in shaping the path to tomorrow. We provide you with comprehensive support to ensure that you operate safely, sustainably and efficiently for many years to come.
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