Are you planning to manufacture a substance for the first time?

Is it hazardous?

Before you start manufacturing, you need to know if you need to register the substance and classify each hazardous substance you place on the market.

If you intend to manufacture one tonne or more of a substance a year, you need to register it with ECHA. This means providing information about the properties and hazards of the substance, including how it can be used safely.

If you do not register your substance, it will be illegal to manufacture it and/or to place it on the market. There is a basic rule: no data, no market.

How much information is required depends on the production tonnage and the hazards associated with your substance. The lower the tonnage and less hazardous the substance, the less information you need to give.

The purpose of the information is to make sure that your substance is used safely. You need to keep the information up-to-date, and provide it when required to your customers in a safety data sheet and, for the more hazardous substances, also to consumers.

Registration is done jointly with the other manufacturers, importers or Only Representatives of the same substance. You are also required to share the data needed for registration with them.

Before placing a substance on the market, you must establish if it is hazardous by applying the classification criteria set out in the CLP Regulation. Classification is required for each substance regardless of the quantity in which it is supplied. 

a. Classification, labelling and packaging is compulsory for all hazardous substances

Classifying a substance as hazardous triggers specific labelling and packaging requirements. You have to notify ECHA of the classification and labelling within one month of placing a hazardous 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.

b. 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.

A decision by the European Commission to put a substance on the Candidate List triggers additional legal obligations for you as a manufacturer to communicate information on the safe use of the substance to your customers.

You can continue supplying the substance, but you will have to monitor if it is selected and included in 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 to a safer alternative.

c. Substances of very high concern requiring authorisation

Substances of very high concern, which move from the Candidate to the Authorisation List, cannot be placed on the EEA market for a use after a given "sunset date", unless:

• Your company or your immediate downstream user is granted an authorisation for a specific use of the substance 
• A total or partial 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 included in the Authorisation List and no exemption applies, you will 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, if it is possible to substitute it with safer alternative substances or technologies, the costs of applying and the benefits and risks from continued use.

d. 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 limitation of concentration levels of a substance in mixtures or in articles

Examples include the ban on asbestos and the restrictions on the manufacture, placing on the market or use of phenylmercury compounds, applied for coatings, adhesives, sealants and elastomers.

You have to comply with the restrictions. You need to be aware of any restrictions and monitor the upcoming ones regarding the substances you manufacture. ECHA publishes information and launches public consultations before a decision on a restriction is taken.