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REACH Regulation – requirements to manage your chemicals in European Union market
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Please contact us – Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – Registration, Only Representative, Authorisation, REACH/CLP Screening – just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu or skype ekotox.bratislava
Equal standards for chemicals’ manufacturing, supply, and safe use span the European Economic Area (EEA), encompassing EU, Iceland, Liechtenstein, and Norway. These rules apply to all companies, regardless of their supply chain role or products.
The REACH Regulation governs various sectors—manufacturing, importing, distributing, or using chemicals, not just the chemical industry.
It applies to your company, no matter its size.
You assume responsibility for safe substance use and must share usage details through the supply chain. Consumers can inquire about high-concern substances in your articles.
Your obligations hinge on your product type:
- Solitary substances, even metals
- Mixtures or articles
Additional rules pertain to hazardous products on the market.
Manufacturer
You are a manufacturer if:
- As an individual or a company you are based in the EEA, and
- You produce or extract a chemical substance
- When you buy a substance directly from a company based outside the EEA and bring it into the EEA territory, you have the same responsibilities as a manufacturer. You have to register the substance to ensure access to the EEA market.
- When you buy mixtures, the requirements apply to each individual substance contained in the mixture.
- You are an importer if you buy a chemical product directly from a supplier based outside the EEA and bring it into the EEA territory.
If your non-EEA supplier has appointed an EEA-based “Only Representative” to register the substance, you are regarded as a downstream user under REACH.
Substances (including metals)
Mixtures (for example, paints, lubricants), or
Articles (for example, car tyres, furniture and clothing)
You will have to comply with additional requirements if you place hazardous products on the market.
Importer
The EU legislation sets the highest chemical safety standards in the world. Your responsibility is to make sure that the chemicals and products you bring into the EEA comply with these requirements.
You are an importer if you buy a chemical product directly from a supplier based outside the EEA and bring it into the EEA territory.
If your non-EEA supplier has appointed an EEA-based “Only Representative” to register the substance, you are regarded as a downstream user under REACH.
Only representative
Companies based outside the EEA can appoint a European-based only representative to take over the tasks and responsibilities of importers for complying with REACH. This can simplify access to the EEA market for their products, secure the supply and reduce the responsibilities for importers.
Only representatives have to be:
- A natural person or legal entity established physically in the EEA
- Equipped with sufficient knowledge in the practical handling of the substances and information related to them
- Appointed by a mutual agreement with a manufacturer, formulator or article producer, established outside the EEA
- Responsible for complying with the legal requirements for importers under REACH
Only representatives can represent more than one non-EEA supplier, but must keep the information related to each of them separate.
The non-EEA company has to inform the importer(s) within the same supply chain of your appointment as an only representative. These importers are then regarded as downstream users for REACH.
Distributor
The law recognises the role you play between manufacturers and customers in enabling communication about chemical safety in the supply chain. Your active involvement is required to protect people and the environment from chemical risks.
You are a distributor under REACH and CLP if you source a chemical substance or a mixture within the EEA, store it and then place it on the market for someone else (also under your own brand without changing its chemical composition in any way.
For example, retailers and wholesalers are distributors under REACH and CLP.
You are not a distributor, whenever:
- You buy chemicals from outside the EEA and place them straight on the market in the EEA. If so, you are an importer.
- You buy chemicals within the EEA and mix them with other chemicals, dilute them or (re)fill containers, before supplying them to others. If so, you are a downstream user.
Downstream user
You are a downstream user, if:
- You are established in the EEA, and
- The supplier of a substance or mixture you use is also established in the EEA, and
- Do you use chemicals in your industrial or professional activities?
You are not a downstream user, whenever:
The supplier of a substance you use is established outside the EEA and has not designated an only representative to register the substance and ensure its access on the EU market. If this is the case, you are an importer.
You only store chemicals and place them on the market (without changing their composition or packaging). Then you are a distributor.
You buy a product and you use it yourself outside an industrial/professional setting. If so, you are a consumer.
Consolidated version of the REACH Regulation (EN 01.01.2021)
https://eur-lex.europa.eu/legal-content/en/TXT/HTML/?uri=CELEX:02006R1907-20210101http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02006R1907-20161011&from=EN
Regulation on the Joint Submission of Data and Data-sharing
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0009&qid=1453380621080&from=EN
Test Methods Regulation
http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02008R0440-20160304
Fee Regulation
http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02008R0340-20150625
Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – Registration, Only Representative, Authorisation, REACH/CLP Screening; Products Legal Compliance on EU Market; Biocides; Cosmetics…
just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu.
REACH REGULATION