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Understanding REACH Regulation

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    What Is REACH Regulation?

    REACH is the Regulation for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It is based on the principle that manufacturers, importers, and downstream users are responsible for ensuring that the substances they manufacture, place on the market, or use do not adversely affect human health or the environment. The responsibility for the management of the risks of substances lies with the natural or legal persons who manufacture, import, place on the market or use these substances in the context of their professional activities.

    The registration provisions require manufacturers and importers to collect or generate data on the substances they manufacture or import. They must use this data to assess the related risks and develop appropriate risk management measures to control these risks. To ensure that they meet these obligations, as well as for transparency reasons, manufacturers and importers must prepare a registration dossier in IUCLID3 format (by using the IUCLID software application) and submit it to ECHA via REACH-IT. Registration applies to the manufacture, import, placing on the market and use of substances on their own, in mixtures or in articles.

    There are two key concepts in REACH that go beyond the former chemical control schemes:

    • The industry is responsible for the safe use of chemicals, while ECHA and other regulators focus their efforts on spot checks and particularly problematic areas.
    • Risk assessment is central to the various REACH processes.

    What are the basics of REACH Regulation?

    The basics of REACH Regulation can be divided into three headings. These are are the protection of human health and the environment, promotion of alternative methods and free circulation of substances. As well as providing protection, the REACH Regulation encourages companies to develop alternative methods for the assessment of hazardous properties of substances. It also ensures the free circulation of substances on the internal market.

    What are the obligations of the REACH Regulation?

    REACH is an acronym for “Registration, Evaluation, Authorisation and Restriction”, which basically implies the obligations it burdens.

    The first step of these obligations is registration. Companies must prepare their substances’ dossiers in IUCLID format and submit them via REACH-IT to ECHA. They must provide information on the properties and uses of the substances and guidance on safe use. The next step, evaluation, includes the evaluation conducted by the ECHA and member states. In this evaluation, the risks of substances are assessed. Another step is authorisation which is required for certain substances of very high concern for specific uses. Lastly, restriction includes restriction of the manufacture, placing on the market, or use of certain substances that pose unacceptable risks

    Companies must comply with the REACH Regulation to place their product on the market safely. They must identify and manage risks related to the substances they manufacture or market in the EU. After that, they must provide information to ECHA on their safe use. Also, they must inform users about risk management measures. This way, the protection of human health and the environment will be promoted and companies will not face any legal penalty.

    What is the REACH Regulation in the UK?

    The United Kingdom harmonised the REACH Regulation into its legislation with some adjustments for domestic purposes. UK REACH came into effect on January 1st, 2021, after the United Kingdom exited from the EU.

    The main purpose of UK REACH is to provide a high level of protection for human health and the environment. And just like in the EU REACH, manufacturers and importers of chemicals exceeding 1 tonne per year need to register them and assess their risks. And they must also provide safety information.  

    What is the REACH Regulation in Turkey?

    Just like the UK, Turkey has its version of the REACH Regulation, known as the KKDIK. It stands for “Kimyasalların Kaydı, Değerlendirilmesi, İzni ve Kısıtlanması Hakkında Yönetmelik” which harmonise “Regulation on the Registration, Evaluation, Authorization, and Restriction of Chemicals”.

    KKDIK also aims to protect human health and the environment, which is why it has similar standards to that of EU REACH. KKDIK Regulation applies to chemical substances that companies manufacture, import, or place on the market above 1 ton per year, on their own, in mixtures, or in articles.

    According to KKDIK Regulation, companies must pre-register and then register these substances with the Turkish Ministry of Environment. The deadlines for these processes depend on the tonnage and hazard level. You can click here to see Chemleg’s related article for more information on the deadlines.

    Appointing an Only Representative in Turkey

    In Turkey, applications related to certain chemicals must be conducted by companies resident in Turkey. Companies not based in Turkey, may appoint an Only Representative in order to fulfil the obligation in case it is required. You can click here to learn about our KKDIK OR Services.

    Frequently Asked Questions – FAQ

    What does REACH compliant mean?

    If a product is “REACH compliant”, it complies with the provisions of the REACH Regulation. In other words, it is safe for the environment and human health.

    What is required for REACH compliance?

    The key requirements for REACH compliance are registration, information provision, and safety data sheets.