Information about REACH

EU Chemicals Regulation: What does REACH reporting apply to?

REACH is the EU chemicals regulation and stands for “Registration, Evaluation, Authorisation and Restriction of Chemicals”. The REACH regulation is based on the European Regulation (EC) No. 1907/2006. Its purpose is to ensure that manufacturers and importers take responsibility for the safe handling of chemical substances and gradually replace harmful products.
“In principle, REACH applies to all chemical substances, i.e. not only those used in industrial processes, but also those found in everyday life, for example in cleaning agents, paints/lacquers, and products such as clothing, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU. (…) Manufacturer: If you manufacture chemicals to use yourself or to supply to others (including for export), you are likely to have to comply with some important obligations under REACH. Importer: If you buy something from outside the EU/EEA, you are likely to have to comply with some obligations under REACH. These may be individual chemicals, mixtures for resale, or finished products such as clothing, furniture, or plastic goods. Downstream users: most companies use chemicals, sometimes without even realizing it. Therefore, you need to check what your obligations are if you work with chemicals as part of your industrial or professional activities. You may have to fulfill some obligations under REACH. Source: European Chemicals Agency ECHA
The European Chemicals Agency (ECHA) is an EU authority in Helsinki that was created to manage the technical, scientific and administrative aspects of the REACH Regulation. The regulation applies in all EU member states as well as in the European Economic Area and stipulates that only previously registered chemicals may be put into circulation. This is intended to make it easier to trace where substances are used that cause damage to the environment or serious adverse health effects.
Substances identified as “Substances of Very High Concern” (SVHC) are added to the SVHC Candidate List by the European Chemicals Agency ECHA. New SVHCs are added to the candidate list twice a year, usually in June and January. The substances on the candidate list may continue to be used, but a reporting obligation applies from 0.1% mass percent (w/w) to the customers of articles containing such substances.    The ultimate aim of the REACH reporting obligation is to manage the risks posed by SVHC. Non-hazardous alternatives are to gradually replace substances that have been shown to pose a risk to the environment or health. The SVHC candidate list includes substances that meet at least one of the following criteria:  
  • carcinogenic
  • mutagenic
  • toxic for reproduction
  • (very) persistent
  • (very) bioaccumulative or toxic
  • endocrine effects     
  • persistent, bioaccumulative or toxic potential. 
However,  the SVHC substance will sooner or later also be included in the REACH authorization list or in Annex XIV of the REACH Regulation. From the “sunset date” mentioned there on, the substance may neither be imported nor manufactured or used in European production. The time between listing on the candidate list and listing on the authorization list can vary. Manufacturers are required to disclose to their customers information about substances that are listed on the REACH Authorization Listeste”. Special regulations and reporting requirements apply to articles containing such substances. In addition, Annex XVII of the REACH Regulation contains substances that may not be produced, used or placed on the market, or may only be produced, used or placed on the market to a limited extent because of their health risks or environmental hazards. This annex is continuously adapted and supplemented by amending regulations. Restrictions can be imposed on individual substances as well as on mixtures or articles containing a particular substance. Therefore, REACH can affect the entire supply chain, from manufacturers, importers and distributors to downstream users or those placing substances on the market.  The ultimate aim of the REACH reporting obligation is to manage the risks posed by SVHC. Non-hazardous alternatives are to gradually replace substances that have been shown to pose a risk to the environment or health. The SVHC candidate list includes substances that meet at least one of the following criteria: carcinogenic mutagenic toxic for reproduction (very) persistent (very) bioaccumulative or toxic endocrine effects persistent, bioaccumulative or toxic potential. However,  the SVHC substance will sooner or later also be included in the REACH authorization list or in Annex XIV of the REACH Regulation. From the “sunset date” mentioned there on, the substance may neither be imported nor manufactured or used in European production. The time between listing on the candidate list and listing on the authorization list can vary. Manufacturers are required to disclose to their customers information about substances that are listed on the REACH Authorization Listeste”. Special regulations and reporting requirements apply to articles containing such substances. In addition, Annex XVII of the REACH Regulation contains substances that may not be produced, used or placed on the market, or may only be produced, used or placed on the market to a limited extent because of their health risks or environmental hazards. This annex is continuously adapted and supplemented by amending regulations. Restrictions can be imposed on individual substances as well as on mixtures or articles containing a particular substance. Therefore, REACH can affect the entire supply chain, from manufacturers, importers and distributors to downstream users or those placing substances on the market.
Manufacturers and importers must apply for a REACH registration number (REACH certificate) for SVHC imported into the EU or produced in an EU member state in quantities of one ton or more per year. This is followed by an assessment of whether alternative substances or technologies can be used and whether the chemicals used are REACH-compliant. If exposure does not exceed certain thresholds or if socioeconomic benefits outweigh the risk, ECHA grants its authorization.   Chemicals that are already adequately regulated by other legislation may be exempted from REACH reporting requirements in whole or in part. Among experts, for example, there is a debate as to whether the RoHS Directive has become obsolete since the introduction of REACH, since there are certain overlaps. This leads to duplicate regulations for importers and manufacturers of electrical and electronic equipment. Information submitted to ECHA via the registration process is publicly viewable via a REACH database. This does not include data for which companies have submitted a (fee-based) request for confidentiality (link to ECHA’s PDF “How to protect your confidential business information”). Among other things, the REACH database contains information on the chemical and physical properties of substances and their toxicity to humans and the environment, as well as the quantities marketed in the EU each year. In this respect, REACH also makes a significant contribution to the “democratization of risk knowledge.” In May 2021, the database contained 23,197 substances and 100,979 dossiers. 
The so-called SVHC reporting obligation or REACH reporting obligation has existed since the European chemicals regulation REACH was introduced in 2007. Since January 2021, companies that place articles or products containing so-called SVHC from the REACH candidate list on the market in the EU are also required to enter information about them in ECHA’s SCIP database.   As with the REACH reporting obligation, this concerns products and articles that are manufactured, distributed or imported into the EU and contain SVHC substances with a concentration above 0.1 percent by mass. However, the obligation to register in the SCIP database is not based on the REACH Regulation, but has a different legal basis with the so-called Waste Framework Directive than the REACH reporting obligation to the customer in the presence of a SVHC.   Both reporting obligations coexist and the obligation to enter the SCIP database does not replace the obligation to inform the customer, which results from Article 33(1) of the REACH Regulation. Both obligations are more often confused – but the only thing they have in common is the SVHC list of chemicals of very high concern.   The aim of the SCIP database is to help waste management companies to identify and recycle waste containing chemicals that are hazardous to the environment or health. The information is also accessible to consumers so they can consider sustainability when shopping and be aware of what SVHC substances are in products and how best to use and dispose of items. You can read more about this in our SCIP technical information. We also offer comprehensive advice, services and training on the SCIP database.  
Implementing the European Chemicals Regulation correctly requires extended communication within the supply chain and expert evaluation of data. Downstream users must provide their upstream manufacturers or importers with information on the exact use of chemicals subject to registration. They must also take measures to mitigate the risks of their products.   This is done primarily through the Safety Data Sheet (SDS), also known as the Material Safety Data Sheet (MSDS). Here, in addition to the registration number, restrictive information on use and the approval requirement are recorded, among other things. The EU Chemicals Regulation regulates the exact conditions for creating, forwarding and storing Material Safety Data Sheets. The CLP/GHS Regulation also specifies internationally valid conditions for the creation of Material Safety Data Sheets. For the automotive industry, the international material data system IMDS is an important source for assessing whether products are REACH-compliant. In the IMDS, all materials for vehicle construction are communicated, archived and managed. In 2021, about 14,000 SVHC substances were recorded in the IMDS. The material data documentation system helps automotive manufacturers and their suppliers meet obligations arising from customer product requirements and national or international laws, norms, standards and regulations such as REACH. By submitting an MDS in which an SVHC has been identified to the customer, the supplier has fulfilled its information obligation under Article 33(1) REACH. In addition, the entry in the SCIP database, which has been required since January 5, 2021, can also be transmitted directly to ECHA via an interface in the IMDS. Products and articles are considered REACH-compliant if they meet all the conditions of the EU Chemicals Regulation. To facilitate the verification, the tool “REACH Report” has been developed in the IMDS. However, this is only available with the additional software “A2 – Advanced Accelerator”, which is subject to a charge, and is not included in the free basic version of the IMDS. This report contains all data assigned to a company listed in the IMDS. Material data created by the own company in IMDS or received from suppliers are recorded. Weight information on parts, data on materials and pure substances as well as a classification in REACH/SVHC or GADSL substances are also listed. By the way, the official reports of the ECHA within the framework of the review procedure, which takes place every five years, are also referred to as REACH reports.   We can advise you on which databases, software solutions and tools will make your work easier: IMDS, CDX, ipoint, BomCheck, and DataCross are among the solutions that can provide you with information across the entire supply chain.
1) REACH Helpdesk at the German Federal Institute for Occupational Safety and Health (BAUA) www.baua.de/DE/Themen/Anwendungssichere-Chemikalien-und-Produkte/Chemikalienrecht/REACH/REACH_node.html   2) REACH information from the European Automobile Manufacturers’ Association (ACEA)     www.acea.be/news/article/reach-registration-restriction-evaluation-and-authorisation-of-chemicals 3) Requirements for substances in articles (ECHA, 2017). 4) Articles – requirements for producers, importers and distributors. (REACH-CLP Biocide Helpdesk).  Adobe PDF file icon 32×32 5) The REACH-CLP Biocide Helpdesk of the federal authorities  www.reach-clp-biozid-helpdesk.de 6) The European Chemicals Agency (ECHA)  https://echa.europa.eu/de/ 7) Information from the Federal Environment Agency  www.umweltbundesamt.de/themen/chemikalien/reach-chemikalien-reach 8)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council Adobe PDF file icon 32×32 9) Automotive industry guidelines on REACH (English)    Adobe PDF file icon 32×32 10) Information on the planned SCIP database (English) https://echa.europa.eu/scip-database 11) A compilation of all original texts on REACH  Adobe PDF file icon 32×32 12.) Report of the ECHA in the context of the review procedure which takes place every five years: https://ec.europa.eu/growth/sectors/chemicals/reach/review_en   13) “Guidance on registration under REACH” from BauA: https://www.baua.de/DE/Angebote/Publikationen/Berichte/REACH-A.pdf?__blob=publicationFile&v=3

Services around REACH

Do you need help with the verification of REACH conformity or advice on the correct handling of the legal requirements? Then you have come to the right place, because we offer competent help from our experienced staff within the shortest possible time. Make an appointment now for a free initial consultation! Or are you looking for REACH training? At our ipCampus you will find training courses worldwide and in many languages.