Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services
– just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu or skype ekotox.bratislava
REACH Registration – registration of chemicals in European Union market
You have a question or need assistance?
European Union chemicals legislation – REACH Regulation require registration of chemicals in case of:
- EU manufacturer or importer of substances on their own or in a mixture;
- EU producer or importer of articles meeting the criteria explained in the Guidance on requirements for substances in articles.
Registration applies to substances manufactured or imported into the EU in quantities of 1 tonne per year or more.
The final deadline is 31 May 2018 for substances in range of 1 – 100 tonnes per year.
REACH Registration applies to substances on their own, substances in mixtures and certain cases of substances in articles. Chemical substances that are already regulated by other legislations such as medicines, or radioactive substances are partially or completely exempted from REACH requirements.
REACH Registration is based on the “one substance, one registration” principle. This means that manufacturers and importers of the same substance have to submit their registration jointly. The analytical and spectral information provided should be consistent and sufficient to confirm the substance identity.
For substance registration a fee is usually charged.
REACH Registration / REACH Pre-Registration
REACH is based on the principle that it is for manufacturers, importers and downstream users to ensure that they manufacture, place on the market or use such substances that do not adversely affect human health or the environment. The responsibility for the management of the risks of substances lies therefore with the natural or legal persons that manufacture, import, place on the market or use these substances in the context of their professional activities.
Registration is required for all substances manufactured or imported in quantities of one tone or more per year per manufacturer or importer unless they are exempted from the scope of registration. The registration requirement applies to all substances irrespective of whether they are hazardous or not. This includes substances on their own, in mixtures or substances in articles when they are intended to be released under normal or reasonably foreseeable conditions of use.
Data Collection and Hazard Evaluation
Companies are responsible for collecting information on the properties and uses of the substances they manufacture or import above one tonne a year. They also have to assess the hazards and potential risks presented by the substance.
This information is communicated to ECHA through a registration dossier containing the hazard information and, where relevant, an assessment of the risks that the use of the substance may pose and how these risks should be controlled.
For your registration, you need to collect information on your substance and share it with the other companies registering the same substance. This applies in particular to ecotoxicological and toxicological information. By sharing data you can avoid unnecessary testing on animals and reduce costs.
You will need to agree on the information to be submitted for a substance and register it jointly, although not necessarily at the same time. ECHA’s data-sharing processes (pre-registration and inquiry) will help you to get in contact with other registrants, and must be followed before you register.
You will have to comply with additional requirements if you place 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.
Consolidated version of the REACH Regulation
http://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
– just call us +421 2 45943712, send an e-mail on ekotox(at)ekotox.eu or skype ekotox.bratislava
