Information about REACH
The EU Chemicals Regulation – what do REACH reporting obligations apply to?
REACH is the name of the EU Chemicals Regulation and is an abbreviation for the “Registration, Evaluation, Authorisation and Restriction of Chemicals”, officially known as European Regulation (EC) Nr. 1907/2006. Its aim is to ensure that manufacturers, suppliers, and importers assume responsibility for the safe handling of chemical substances and gradually find replacements for hazardous products.
“In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has implications for most companies across the EU. (…)
Manufacturers: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.
Importers: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished articles, like clothes, furniture, or plastic goods.
Downstream users: Most companies use chemicals, sometimes even without realizing it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH”
Source: European Chemicals Agency (ECHA)
The ECHA is an EU agency based in Helsinki. It was established to regulate the technical, scientific, and administrative aspects of the REACH Regulation. The Regulation applies to all EU Member States and the European Economic Area. It ensures that only previously registered chemicals are now permitted to be placed on the market. The aim is to be able to trace where substances are in use that cause harm to the environment or serious health problems to humans.
The ECHA includes substances that had been identified as SVHCs (Substances of Very High Concern) in the SVHC Candidate List. New SVHCs are entered in this list twice a year, usually in June and in January. The substances on the Candidate List may still be used; however, if they occur in a concentration of more than 0.1% weight by weight (w/w), there is an obligation to notify customers that the articles in question contain these substances.
The aim of reporting requirements under REACH is ultimately to control the safety risks posed by SVHCs. Non-hazardous alternatives should gradually replace those substances that have been proven to pose a risk to the environment or human health. Substances are included in the SHVC Candidate List if they cause at least one of the following safety risks:
- reproductive toxicity
- (very) persistent
- (very) bioaccumulative or toxic
- endocrine disrupting
- persistent, bio-accumulative and/or toxic potential
At some point, however, an SVHC will also be included in the REACH Authorisation List and/or in Appendix XIV of the REACH Regulation. The substance may not be imported, produced, or used in production in Europe after the “Sunset Date” given in the list. The length of time that elapses between listing on the Candidate List and listing on the Authorisation List may vary greatly.
Manufacturers have a duty to disclose information to their customers about substances listed in the REACH Authorisation List. Special provisions and reporting obligations apply to articles containing such substances.
Furthermore, Annex XVII of the REACH Regulation includes substances that may not be produced, used, or placed on the market on account of the risks they pose to human health or the environment or they may only be produced, used, or placed on the market in limited amounts. This annex is adjusted and amended on an ongoing basis through Amending Regulations. Both individual substances and mixtures or articles containing a certain substance can be restricted. This is why REACH can affect the entire supply chain, from manufacturers, importers and merchants to downstream users and commercial distributors.
Manufactures and importers must obtain a REACH registration number (REACH Certificate of Compliance) for SVHCs that are imported in the EU or are produced in an EU Member State from a volume of one ton per year. This is followed by an assessment to determine whether alternative substances or technologies can be used and whether the chemicals used comply with REACH. If exposure does not exceed certain thresholds or if the socio-economic benefit outweighs the risk, the ECHA will issue authorization.
Chemicals that are already adequately regulated by other statutory provisions can be completely or partially exempted from the REACH reporting obligation. For example, there are ongoing discussions among experts as to whether the RoHS Directive has become superfluous since the introduction of REACH as there are certain overlaps. This results in duplicate regulations for importers and manufacturers of electrical and electronic equipment.
Information that is transmitted to the ECHA about the registration procedure can be viewed by the public via a REACH database. An exemption is made for data if companies have submitted a claim for confidentiality. This incurs a fee. (See ECHA file “How to protect your confidential business information”. The REACH database includes details of the chemical and physical properties of substances and their toxicity for humans and the environment in addition to the annual volume marketed in the EU. In this respect, REACH plays a considerable role in the “democratization of risk knowledge”. 23,197 substances and 100,979 dossiers had been entered into the database by May 2021.
Mandatory reporting of SVHCs and the REACH reporting obligation have been in force since the European Chemicals Regulation REACH was introduced in 2007. Since January 2021, companies that place articles or products with SVHCs from the REACH Candidate List on the market in the EU are additionally required to enter information about them in the ECHA’s SCIP database.
As with the REACH reporting requirements, this concerns products and articles that are manufactured, distributed, or imported in the EU and that contain SVHCs with a concentration of over 0.1% weight by weight. The REACH Regulation does not stipulate an obligation to enter information in the SCIP database. Rather, this obligation has a different legal basis to the REACH reporting requirement for customers when an SVCH is present in that it is stipulated by the Waste Framework Directive.
Both reporting requirements exist in parallel and the requirement for entering information in the SCIP database is not a substitute for submitting the required customer information stipulated in Article 33 (1) of the REACH Regulation. These two requirements are often confused. All they have in common is the SVHC list of chemicals of particular concern.
The aim of the SCIP Database is to help waste management companies to identify and recycle waste that contain chemicals that pose a risk to the environment or human health. The information can also be accessed by consumers so they can take sustainability into account when shopping. It helps them develop an awareness of the type of SVHCs that are contained in articles and how they should best use and dispose of these articles.
Learn Key SCIP facts here. We also offer a comprehensive program of consulting, support services and training courses on the SCIP database.
Putting the European Chemicals Regulation into practice requires more effective communications along the supply chain and the ability to expertly evaluate data. Downstream users have to make information available to their upstream manufacturers or importers regarding exactly how the substances subject to registration are used. In addition, they need to take action to reduce the safety risks from their products.
This is achieved primarily by using Material Safety Data Sheets (MSDS). Restrictive details on the use and requirement for authorization are given here as well as the registration number. The EU Chemicals Regulation governs exactly how the Material Safety Data Sheets are to be created, transferred to other parties, and stored. The CLP/GHS Regulation additionally stipulates international guidelines for creating Material Safety Data Sheets.
The International Material Data System (IMDS) is a key resource for the automotive industry in assessing whether products comply with REACH. All the substances used in vehicle construction are communicated, archived, and managed in the IMDS. Around 14,000 SVHCs were documented in IMDS in 2021. The system for documenting materials data helps automotive manufacturers and their external suppliers to meet their obligations that are the result of product requirements from customers and from national or international legislation, standards, and regulations such as REACH. When a supplier sends their customer an MDS listing an SVHC, they have complied with their obligation to communicate information in accordance with Article 33(1) of REACH. In addition, since January 5, 2021, it has been a requirement to make an entry in the SCIP database and this can also be submitted directly to ECHA via an interface in the IMDS.
Products and articles that satisfy all the criteria in the EU Chemicals Regulation are considered to be REACH-compliant. The Reach Report Tool in the IMDS was developed to make it easier to check this. However, this tool is only available in the fee-based “A2 – Advanced Accelerator” add-on software and not in the free basic version of the IMDS. This report contains all the data attributed to a company listed in the IMDS. The listed materials data are those created by the company itself in the IMDS or those received from the supplier. The list also includes weight information for parts, data on substances and basic materials, and classification as REACH/SVHC or GADSL substances. However, it should be noted that the official reports from the ECHA as part of the five-year review program are also called REACH reports.
We can advise you on which databases, software and tools will make your work a lot simpler. IMDS, CDX, iPoint, BomCheck and DataCross are among the solutions that allow you to access information about the entire supply chain.
Sustainability has become an important consideration not only for end consumers but for increasing numbers of firms along the supply chain too. Pressure has been growing globally for years for firms to manufacture and market articles that have a reduced environmental footprint and are not harmful to health. Now the publicly accessible SCIP database is available to end consumers and provides advanced features that allows them to check a product’s sustainability credentials and make use of their consumer rights to access data. In this context, the Federal Environment Agency (UBA) has developed the Scan4Chem app for smartphones as part of the European AskREACH project. This allows consumers to scan barcodes on products and retrieve an analysis of the chemicals contained in them or to send inquiries to firms. It is therefore to be expected that European vendors will be increasingly confronted with inquiries about the sustainability of their products and the type of chemical substances they contain. They will have to put measures in place so they are able to provide this information.
Businesses often have to use so much time and resources managing their REACH obligations, it is generally more cost-effective to use specialist REACH support services. If you need advice on ensuring your products comply with REACH or receive questions about REACH from companies that are not IMDS customers, then it’s time to talk to us. Our specialists are part of an international network of compliance professionals. This ensures they have up-to-the minute knowledge and plenty of hands-on experience to help you get on top of your REACH obligations. They can provide high-quality training on our REACH courses and deliver high-quality REACH consulting and support services. We can also help you manage any other compliance obligations you have such as those relating to biocides, conflict minerals and SCIP. We would be glad to advise you on how to make the most efficient use of workflow management software
Outsourcing your Product Environmental Compliance work will free up resources so you can concentrate on your core business. Just leave everything to us – we provide a reliable service and will make sure you always have the lowdown on REACH requirements.
Let us know how we can help. Contact us to arrange a free initial consultation.
|REACH Helpdesk at the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin or BauA)||Link|
|Information on REACH from the European Automobile Manufacturers’ Association (ACEA)||Link|
|Requirements for substances in articles (ECHA, 2017)|
|Articles – requirements for producers, importers, and merchants (REACH-CLP Biocides Helpdesk)||Link|
|The German government’s REACH CLP Biocides Helpdesk||Link|
|European Chemicals Agency (ECHA)||Link|
|Information from the German Federal Environment Agency||Link|
|Regulation (EC) 1907/2006 of the European Parliament and of the Council||Link|
|Information about the planned SCIP database (English)||Link|
|Compilation of all the original texts on REACH||Link|