The REACH regulation is an EU legislation that aims to protect human health and the environment against the risks arising from chemical substances, while promoting new testing and research methods for these substances in order to minimise animal testing. Let’s not forget that during their manufacture and use, chemicals can seriously affect human health and ecosystems, so the REACH regulation seeks precisely to establish all the necessary measures and controls to avoid these risks.
Companies that market chemical substances – or modified natural substances – within the EU must comply with the REACH regulation, identifying the hazards of these substances and all their chemical properties, as well as establishing the safest way to use them. In order to be able to sell chemicals within the EU, these companies must therefore obtain a REACH certificate: that’s the reason why many of them contact us to get the expert assessment and advice provided by Kaeltia’s regulatory service. But, let’s take a closer look at what REACH regulation is, and why it is so important.
What is the meaning of REACH?
REACH stands for Registration, Evaluation, Authorisation and restriction of CHemicals. When we talk about REACH Regulation, we are referring to the EC Regulation No 1907/2006, which entered into force on 1 June 2007, and aims to protect human health and the environment from the risks of chemicals.
What stipulates the EU REACH legislation?
The REACH regulation specifies that companies must identify the properties and risks associated with the chemical substances that they manufacture and sell on EU territory, providing information on how to use them safely. To this end, the REACH regulation sets out a series of obligations for these companies, such as the need to obtain a REACH registration number, or to notify the chemical substances in the products that are sold in the European market.
However, the text of the REACH regulation states that not all companies are subjected to the same regulatory obligations, but that this will depend on the role of that company in placing the chemical on the market.
Who is REACH mandatory for?
REACH is a cross-cutting regulation that, with several degrees of involvement, implies obligations for most companies – even those that may at first sight appear to be outside the chemical industry. Depending on the type of activity carried out by each company within the production and/or distribution process of chemical substances, the REACH regulation establishes the following types of enterprises:
- Manufacturers: companies based in the EU that manufacture chemicals, either for their own use or for sale or export. These are probably the companies with the most obligations according to REACH.
- Importers: European companies that bring chemicals acquired outside the EU or EEA into their territory; this includes not only chemicals or mixtures, but also finished products such as clothing, devices, plastic products…
- Middle users: this refers to EU companies that use or handle chemicals.
- Distributors: these are European companies that do not use chemicals, but are responsible for their storage, distribution and/or sale to third parties.
- Producers: refers to European companies that produce or manufacture within the EU products that may contain chemicals.
Representatives: this refers to EU companies that are commissioned – through an exclusivity deal – by companies outside the European Union to make the necessary arrangements to meet the REACH requirements for importers.
Regarding companies based outside the EU, they are not obliged to comply with REACH, even if they export their products to EU territory; in this case, however, the obligations under REACH legislation fall on the EU-based companies importing those products, or on the exclusive representatives arranged by these non-EU companies.
How does REACH work?
The ECHA (European Chemicals Agency), created in 2007 and based in Helsinki, is the organisation in charge of applying the REACH legislation, whose task is to help companies to comply with the REACH regulations; this is carried out by providing them with all kinds of information on chemical substances, and handling the reports on these substances that ECHA receives from companies. However, ECHA does not have the capacity to enforce the REACH regulation, but this role is assumed by the competent authorities of each EU-member country.
The REACH regulation requires companies to carry out and submit several laboratory tests; in practice, this means that companies must identify the risks of the chemical substances they manufacture and/or market on European territory, demonstrate to ECHA that they can be used safely, and inform users about how to deal with these risks and avoid them.
This is where Kaeltia comes in, helping companies to understand which parts of the REACH regulation they are obliged to comply with, what information they need to collect, what reports they must issue, and – finally – how to submit all these documents to the competent authorities, monitoring all the process until they obtain the certificate, if needed.
Then, an ECHA scientific committee will consider the company request; if ECHA considers that the risks associated with the chemical cannot be managed properly, it may apply restrictions on its use, or even completely ban it. In any case, the spirit of the REACH regulation also involves the progressive substitution of those more hazardous substances with less dangerous alternatives.
What chemicals are included in the REACH regulation?
REACH applies not only to chemicals used in industrial processes, but also to chemicals commonly used in people’s homes: from cleaning products or paints, to clothing or electronic devices. That’s why, in the end, this regulation affects almost every company operating in the European Union.
By principle, REACH concerns any chemical substance that is imported or manufactured in the EU, whether it is mixed or contained in any form in products and devices, except for the exceptions set out in the Art. 2 of the REACH Regulation (radioactive substances, transported substances, waste…). The full list of substances subjected to the authorisation process is included in REACH Annex XIV, also called REACH authorization list; this list can also be extended when necessary to include new chemical substances: this is what happened with the last update of the REACH regulation in 2022.
Up to 17 January 2023, REACH Annex IV includes about 59 chemical Substances of Very High Concern (SVHC), such as CMRs (Carcinogenic, Mutagenic and Reprotoxic chemicals, that may cause cancer, genetic mutations, and reproductive or birth defects) or phthalates, which are one of the world’s most common plasticisers but also a powerful endocrine disruptor.
Among the most recent updates of the EU REACH regulation is the new legislation applicable to fertilisers; the new Regulation on Fertilising Products (FPR) – (EU) 2019/1009 – regulates the marketing of EU fertiliser products, and after it came into force it has modified the requirements of the REACH regulation that were mandatory in the European Union. From now on, only if the fertilising product is placed on the market under the new FPR Regulation, will the new REACH requirements – known as REACH+ (REACHplus) – apply to it.
The FPR stipulates that all substances that make up an EU fertiliser product must be registered under REACH by means of a dossier containing, as a minimum:
a) the information requirements described in REACH for the >10 T/year tonnage band (mandatory minimum tonnage, more restrictive requirements than lower tonnage)
b) a chemical safety report, analysing the use of the substance as a fertiliser; if the fertiliser product is placed on the market without CE marking it will not be considered as an EU fertiliser product, and then the usual REACH requirements apply: that is, the REACH dossier corresponding to the tonnage range being manufactured or imported, shall be submitted for registration as usual.
What is the CLP regulation?
While REACH is responsible for evaluating, authorising and – if needed – restricting chemicals used in the EU, the CLP regulation is responsible for the classification, labelling and packaging of chemicals and their mixtures. In short, CLP seeks to identify through labelling all the properties and potential hazards of each chemical substance or mixture, also establishing rules for their packaging.
Like REACH, CLP also imposes a number of obligations on companies depending on their role in the product supply chain. Both REACH and CLP regulations are, therefore, key to the EU’s legislation for assessing and managing chemicals and their risks.
In summary, all the REACH regulation is of key importance to ensure the protection of human health and the environment in the European Union, against the potentially high risks posed by the chemical substances produced and marketed by companies; therefore, it is vital that all those involved in the production and distribution of products using these chemicals are aware of their risks and respect REACH norms.
Precisely, in order to ensure a proper compliance with regulations, Kaeltia Consulting advises and provides technical support to manufacturers, distributors and importers of all types of chemical and natural substances; our services include the following:
- review and making of Safety Data Sheets (SDS)
- review of product labelling, and its adaptation to the destiny country
- review and elaboration of CLP on chemical substances
- elaboration, submission and follow-up of REACH certification dossiers
At Kaeltia, we are committed to quality and best customer experience, offering a professional and flexible service that adapts to every client’s needs. If you have to apply the REACH regulation; if you are not sure if your company must comply with this regulation; if you don’t know how to apply or deal with REACH obligations… We can help you!! Do not hesitate to contact us: let the best professional team deal with it!