Does your company produce, import or use chemicals or chemical products? If yes, then your company likely has obligations in the EUs REACH legislation.
Not sure what they are?
Don’t worry, in this article we’ll take you through all you need to know about the European REACH legislation and how to make sure you comply!
If you are a manufacturer of chemicals or import them into the EU, then you’ll be interested in the registration of substances.
If you are a downstream user, meaning that you buy chemicals from a supplier and use them, then you’ll be mostly interested in your obligations regarding the restriction of use and your communication in the supply chain.
What are REACH Regulations?
REACH is a regulation introduced by the European Union in 2007 to improve the protection of human health and the environment from the risks that can be posed by chemicals. It stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. It was introduced by the European Chemicals Agency (ECHA) and is being implemented in steps over 15 years.
For many years, many chemicals were produced in high amounts and put on the market in Europe. But with many of these chemicals, there was insufficient information on the hazards they posed to human health and the environment.
The REACH regulation was introduced as a way of gathering useful information on all these chemical substances in the European market. The aim was to gather information on all of the chemicals available in the EU in a database in order to reduce the risk to human health and the environment.
REACH inverts the burden of proof
Earlier it was often up to governments to prove that a chemical was dangerous before it could be regulated or taken off the market. REACH inverted this burden of proof. To comply with REACH, manufacturers and importers of chemicals are now the ones required to acquire knowledge of the potentially hazardous properties of the substances and communicate how to use them safely before they can be sold on the European market.
It most likely affects your company too
REACH not only applies to industrial products but also to consumer products like cleaning products, paints and chemicals in articles such as clothes, furniture and electrical appliances.
Additionally, REACH has introduced demands for more effective communication between suppliers and users of chemical substances. The manufacturers and importers of chemicals are required to communicate hazards and safe use of products to the users of chemicals, and the users are required to only use the chemicals in the ways that the manufacturers and importers have deemed safe. This means that your company is very likely affected by REACH.
What is the process of REACH legislation?
The name of the REACH legislation is an acronym that describes the process of registering, evaluating, authorising and restricting the use of chemicals:
If you manufacture or import chemical substances in quantities in excess of 1 tonne per year you have to register the substances with the EU Chemicals Agency.
This also applies to substances that are part of a mixture, and in some cases also to substances in articles. You must also provide information on the environment and health effects of the substance and the risks of using it.
The deadline for registering existing manufactured or imported chemicals in the market in excess of 1 tonne per year was on June 1st 2018.
“No data - no market”
The tenet “No data - no market” is central to REACH and means that as a manufacturer or importer of chemicals, if you do not complete this registration and communicate the information downstream in the supply chain, you are not allowed to sell the product on the European market.
It’s not only about complying with the law
It is important to remember that there is a social responsibility involved with the manufacture and use of chemicals. The registration and restriction of chemicals will aim to reduce the occupational, public health and environmental impact of using chemicals within the EU. Your registration can ultimately benefit your company as it ensures transparency and therefore safe use for your customers.
One of the main goals of REACH is to restrict the use of the most dangerous chemicals, over time. These are known as substances of very high concern.
What are SVHCs?
All EU member states as well as ECHA can propose that a substance be identified as a substance of very high concern (SVHC) in REACH. SVHCs are mostly carcinogenic, mutagenic or toxic for reproduction (CMR) or persistent, bioaccumulative and toxic (PBT and vPvB). ECHA uses the data from the registration to assess the risk associated with the chemicals. If ECHA assesses that a substance is of very high concern (SVHC) and no one objects, then it will be added to the Candidate List. Substances in the Candidate List are candidates for the Authorisation List.
Once every 1 to 1.5 years ECHA assesses which, if any, substances from the candidate list should be moved to the Authorisation List.
This is a very restrictive aspect of REACH as companies who want to use or sell a chemical on this list will need to submit an application and gain authorisation from ECHA before they can legally use the chemical. When applying for the use of a substance on this list you must be able to argue why no alternative, safer chemicals will be able to do the job and why it is necessary to use the one in question.
Substances are prioritised for the Authorisation List if they are persistent, bioaccumulative or toxic (PBT), if they are used widely and thus have the potential to affect many people or much of the environment and if they are used in high volumes.
All EU member states as well as ECHA can also propose that the use of a substance can be restricted if they suspect that it is very dangerous. On ECHAs list of Substances Restricted Under REACH you can see which substances are currently restricted. Some substances are restricted in the ways you can use them. For example you may not be allowed to include the substance in an aerosol product in excess of certain quantities. Other substances are completely forbidden. Check if a substance is regulated before producing or importing it into the EU.
How to comply as a producer or importer
If you produce a substance in amounts over 1 tonne per year or import it into the EU/EEA, then you have to register it with ECHA. The registration requires you to gather or generate information about the chemical properties of the substance and use this information to assess the risks related to using, transporting, storing and disposing of it and to recommend precautionary measures that ensure safe handling to users of the substance. When registering a substance, you will generally need to supply this key information:
- General information on the registrant (you)
- Identification of the substance
- Information on the manufacture and use(s) of the substance
- Classification and labelling of the substance
- Guidance on safe use
- Exposure information for substances registered in quantities of 1 to 10 tonnes.
Manufacturers and importers are obligated to collect all freely available existing information on the properties of the substance for registration purposes or alternatively conduct new research to generate this information. An important aspect of REACH is the focus on sharing existing information with other manufacturers in order to minimise unnecessary animal testing.
You must then collect this information in a chemical safety report, which documents that the risks associated with producing and using the substance can be controlled by implementing specific precautionary measures and then submitting the report to ECHA.
Some substances such as some used in medicines are exempt from registration because they are regulated by different legislation.
Communication in the supply chain for manufacturers, importers and suppliers
A crucial part of making REACH work is that manufacturers and importers of chemicals communicate information on chemical risks downwards in the supply chain when they sell those chemicals.
Safety data sheets
If you are a manufacturer or producer of hazardous substances you must prepare safety data sheets that inform your customers about the chemical properties and hazards of using, transporting and storing the substance or mixture and what precautions must be taken to do so safely.
A safety data sheet is required for a substance or mixture if:
- it meets the criteria for classification as hazardous according to CLP
- it is persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB)
- it is included in the candidate list for eventual authorisation according to Article 59 (1) of REACH for any other reasons.
Safety data sheets are required for substances and mixtures, but are not required for articles.
If you manufacture or import more than 10 tonnes of a substance per year, you also have to prepare a list of exposure scenarios as part of the registration. Exposure scenarios are a list of ways the chemical product may be used safely. You must send the exposure scenarios to your customers along with the shipment of the chemical product. Downstream users of the product are only allowed to use the product in one of the ways described in the exposure scenarios.
If new information is found regarding the chemical attributes and risks of a substance, manufacturers and importers must send a revised version of the safety data sheet to customers who bought the substance in the past 12 months.
How to comply as a downstream user
Downstream users do not have the obligation to register chemical substances, but have other duties in REACH. They are responsible for using the chemicals in a safe way as described by their suppliers and communicating new information upwards in the supply chain.
Safety data sheets
To comply with REACH when using chemicals, you must use the chemicals in a way that is safe for your employees and for the environment. This is done by making sure you have access to the newest safety data sheets with information on the risks associated with any dangerous chemicals you are using, storing or transporting. Based on the information in the safety data sheets you must apply the appropriate measures to control the risks posed by the substance.
If the safety data sheet has a set of exposure scenarios attached, you are furthermore only allowed to use the chemical product in a way that is specified in the exposure scenarios. If your use is not described in an exposure scenario that means that the manufacturer or importer has not included that use in their risk assessment and doesn’t know if it is safe to use that way.
Because suppliers only have to send a revised version of the safety data sheet to you as a customer if you bought the substance in the past 12 months, the responsibility to keep the newest information falls on you as the downstream user, if you have chemical products older than a year.
Communicating upwards in the supply chain
The information must not only flow downwards in the supply chain. Producers and suppliers may themselves have limited knowledge of the actual uses of the substances. Therefore, if a downstream user finds that the exposure scenarios are not applicable or comes upon new potential hazards not described in the safety data sheet, they must communicate this back to their suppliers and manufacturers so they are able to risk assess the new use in an exposure scenario.
REACH is working to restrict the use of more and more dangerous chemicals. If your company uses a chemical that may be restricted in the future, it is wise to start finding an alternative as soon as possible, as you may otherwise find yourself in a situation where you need to stop using a chemical that is critical to your work.
Manage your chemical safety documents
We hope this article has helped you understand REACH and what you need to do to comply, no matter if you are a manufacturer, importer or downstream user. EcoOnlines software Chemdoc is created especially to help companies like yours comply with the REACH legislation. Our chemical safety expertise can help connect manufacturers and importers of chemicals with the downstream users, ensuring that legally required information flows seamlessly between these parties.
Contact us if you want to know more about how your company can benefit from the digital chemical safety documentation and communication features of EcoOnlines Chemdoc.