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.
What do I have to do?
This depends on the type of products you import:
- 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.
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.
Before you place a substance or a mixture on the EEA market, you must establish if it is hazardous by applying the classification criteria set out in the CLP Regulation. You are required to do this for each substance on its own or in a mixture, regardless of the quantities which you supply.
Classification, labelling and packaging is compulsory for all hazardous substances and mixtures
Classifying a substance or a mixture as hazardous triggers specific labelling and packaging requirements. You must notify ECHA for each hazardous substance placed on the market on its own or in a mixture within one month of placing the product on the market. You must provide the relevant information in the safety data sheet and use hazard labels to communicate the risks and ensure safe handling by your customers.
Substances of very high concern
REACH sets out criteria to identify substances of very high concern (SVHCs) for human health and the environment. Substances which meet these criteria are being identified all the time. The substances are included in the Candidate List for Authorisation, which is updated every year in June and December, and published on ECHA's website.
This is the first step in the REACH authorisation procedure which aims to control the risks from the most hazardous substances on the EEA market and ultimately replace them with viable safer alternatives.
If a substance you import on its own or in a mixture is identified as being of high concern and added to the Candidate List for Authorisation, you will have the additional obligation to communicate information on the safe use of the substance to your customers.
You can continue supplying the substance, but you will have to watch out for it being added to the Authorisation List. This may only be a question of time and you may choose to gain business advantage by moving away from a substance of very high concern before you are legally required to do it.
Substances of very high concern requiring authorisation
Substances of very high concern, which have moved from the Candidate to the Authorisation List, cannot be placed on the EEA market for a use after a given "sunset date", unless:
- You or your immediate downstream user is granted an authorisation for a specific use of the substance
- A general or specific exemption applies, for example, if you use the substance for scientific research and development
Authorisation is required regardless of the amount of the substance used.
If your substance is on the Authorisation List and no exemption applies, you have to choose whether to:
- Stop placing it on the market, or
- Apply for authorisation, or
- Investigate the possibility of being covered by an authorisation granted to your immediate downstream users
Whether or not to apply for authorisation is a business decision, based on how critical the substance is, whether it is possible to substitute it with alternative substances or technologies, the cost of applying for authorisation, the benefits and risks from continued use.
Substances under restriction
Substances that pose an unacceptable risk for human health and the environment are restricted. This can mean:
- A total ban
- A restriction of marketing and specific uses, or
- A limit on concentration levels of a substance in mixtures
One example is the restriction on toluene in adhesives or spray paints intended for supply to the general public.
You have to comply with the restrictions. You need to be aware of any restrictions and monitor the upcoming ones regarding the substance you import. ECHA publishes information and launches public consultations before a decision on a restriction is taken.
You will need information on the substances contained in the articles. In particular:
- Are there substances intended to be released during use of the article, for example, in a scented toy or a scented bin-liner? If there are, and the substances are present in your imports at more than one tonne a year, you will have to register them, unless they have been already registered for that use
- Are there any substances of very high concern? If there are and if they are above a certain concentration, you must provide sufficient information to your customers to allow safe use of the product. This is required as soon as the substances are added to the Candidate List. You must also notify ECHA in specific cases
- Are there any restricted substances in articles, for example, lead in jewellery? You have to comply with the restrictions and if required, stop your imports