REACH

Candidate list of substances

One of the aims of the REACH Regulation is to gradually replace extremely dangerous substances with other, less dangerous substances or technologies, if and when these new options become economically and technically viable.

What is the candidate list of substances?

The candidate list of substances includes all substances of very high concern (SVHC) that Member States or the ECHA have submitted to the European Commission, with the aim of regularly evaluating these substances and taking measures to limit their use.

Which substances may be considered extremely dangerous (SVHC)?

An extremely dangerous substance (SVHC, or a Substance of Very High Concern) may have some of the following risk characteristics:

Reproductive carcinogenicity, mutagenicity and/or toxicity (1A or 1B),
PBT and/or vPvB,
Endocrine disrupting properties (for health or the environment),
Respiratory sensitization properties,
Specific toxicity in certain organisms after repeated exposure,
An equivalent degree of concern that has likely serious effects on human health or the environment.

Not all SVHCs are included in the candidate list, only those that the Member States or ECHA have submitted to the European Commission.

ECHA regularly evaluates the candidate list of substances with the aim of deciding which ones should be included in the Authorisation List (Annex XIV of REACH).

What are the repercussions for companies of adding a new substance to the Candidate List?

When a substance is added to the Candidate list of substances, all companies that are marketing or using the substance, whether as it is, in a mixture or included in articles, will have to comply with certain legal obligations:

Update the products safety data sheets, stating the presence of said substance,
Minimise the exposure and emission of the substance,
In situations involving articles, inform customers of the presence of such substance and notify the ECHA. You can find out more about the obligations for companies who market articles here.

Does REACH apply to me if I sell articles?

Colloquially, when we talk about chemical products, we think about substances or mixtures that have been manufactured in large factories which emit smoke from their tall chimneys. But in reality, we are surrounded by countless chemical substances and mixtures every day, some of which we are not even aware of.

What is an article?

All substances and mixtures can be combined to form different materials which we use to build objects with the aim of making our day-to-day lives easier; for example, a smartphone with a more durable battery, a lighter aeroplane or an item of clothing that doesn’t crease.

In accordance with the REACH Regulation, we call these objects articles: an object which during production is given a special shape, surface or design that determines its function to a greater degree than its chemical composition. The complexity of these objects increases when we combine several articles to create what we call a complex object.

For example, a bicycle is a complex object that is formed from many different articles, as shown in the illustration below:

Vector de Colorido creado por macrovector – www.freepik.es

What obligations have been established by REACH with regard to articles?

The REACH Regulation has established certain obligations for companies that produce, import and/or market articles:

Communication in the supply chain

All European companies that market an article in Europe must confirm whether the article in question contains any substances of very high concern (SVHC) that are included in the candidate list of substances for authorisation at concentrations higher than 0.1% m/m.

If that is the case, the company is obliged to notify all recipients of the article about the substance(s) included in the candidate list and provide them with necessary information about how to safely use the product.

Notifications about substances present in articles

Companies that produce and/or import articles are obliged to notify ECHA of any substances:

That are of very high concern (SVHC) and that are included in the candidate list of substances for authorisation.
That are present in the articles that the companies produce and/or import at concentrations of < 0.1% m/m.
Whose total annual substance quantity is higher than 1 tonne per year.

REACH Registration

Companies producing or importing articles must register in REACH any substance contained in an article, on the condition that the following two conditions are complied with:

The substance is intended to be released by the article within its normal conditions of use.
The total amount of substance present in the produced or imported articles from which said substance is to be emitted is higher than 1 tonne per year.

However, if the producer or importer of an article can provide documentary evidence that the substance has already been registered by another company for the same use, they will not have to submit their own REACH registration.

It is important to remember that companies that market articles must also comply with the obligation of notifying the SCIP database, in accordance with waste regulations, and in turn they may have to comply with other REACH requirements as downstream users or formulators, for example.

More information

Revision of the REACH and CLP Regulations

With the European Green Deal, the European Commission is hoping to tackle climate change by reducing contamination to achieve a toxic-free environment, with the aim of attaining zero pollution. The Commission hopes to provide the EU with a clean, circular and sustainable economy, and to become carbon neutral in 2050.

As part of those objectives, at the end of 2020 the European Chemicals Strategy for Sustainability was adopted, setting out a series of actions intended to increase the awareness and control of chemical products.

The aim of the Strategy is to better protect citizens and the environment against dangerous chemical products and to encourage innovations within the development of safe and sustainable products, thus promoting the EU industry as a world leader in the production and use of chemical products.

To achieve these objectives, a revision of the rules that regulate the recording, evaluation, authorisation and restriction of chemical products in the EU is required, in addition to a specific revision of the Classification, Labelling and Packaging (CLP) Regulation regarding chemical substances and mixtures.

The REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals, together with the Classification, Labelling and Packaging (CLP) Regulation for chemical products, is a key part of EU legislation for the evaluation and management of chemical products.

The REACH Regulation was last evaluated in 2018 and it was concluded that there were opportunities for improvement, with lapses in the knowledge of many substances. The Chemicals Strategy for Sustainability acknowledges the need for specific revision of the REACH Regulations in order to achieve their objectives.

To achieve the objectives indicated, the strategy also includes the revision of the Classification, Labelling and Packaging (CLP) Regulation for chemical substances and mixtures. This regulation, together with the REACH Regulation, is a fundamental factor in evaluating the dangers of chemical products. It is believed that in several aspects the CLP Regulation has not been kept up-to-date, and in others the regulations are ambiguous and allow for diverging interpretations.

The Commission has introduced a four-week period, starting from 4 May, for receiving feedback from the interested parties, which may include contributions and suggestions. Once this period is over, the Commission shall publish a report with the contributions received and will explain how they are to be applied in the event that the Commission proceeds to do so.

To participate:

For more information

How to sell chemicals in Europe?

What is an Only Representative (OR)?

Importation of chemicals into the European Union is subject to REACH Regulation Regulation (EC) No 1907/2006. REACH forces European companies to register chemical substances imported into Europe above 1T/year. Therefore, non-European exporters selling chemicals in Europe may see their sales minimize due to this obligation for their European customers.

If you are a non-European exporter to the EU and you need to place your chemicals in Europe on equal terms regarding European suppliers, we strongly suggest you reading this article.

Do you need an Only Representative (OR)?

Non-European manufacturers that export chemicals to Europe may sell less due to the registration obligation that affects their European clients.

However, and according to the REACH Regulation, non-European suppliers can appoint a European company to act as their Only Representative (OR) in Europe to register the substances on their behalf, thus releasing its European clients of such obligation.

Any non-European company interested in placing its chemicals within Europe is entitled to appoint an Only Representative (OR)

What advantages does an OR offer you?

As a non-European supplier, you can offer European clients free importation of chemicals in terms of REACH , providing them relevant economical savings, and boosting your commercial competitiveness compared to other European suppliers supplying the very same products.

What can ServiREACH offer you?

ServiREACH facilitates your entrance to Europe by offering you the ONLY REPRESENTATIVE service, guaranteeing full compliance with the REACH Regulation and releasing your European clients from the obligations arising from their activity as importers.

If you export chemicals to the European Union and you need to learn more about the appointment of an Only Representative, do not hesitate to contact us at [email protected].

Do you want to export to the European Union and appoint an Only Representative to streamline the process?

Yes, I am interested

The process of appointing an OR

REACH?… What is REACH?

What is REACH?

REACH is a European Union Regulation (Regulation (EC) No. 1907/2006) implemented to ensure the safety of chemicals for the human health and the environment.

What does it mean REACH?

REACH stands for Registration, Evaluation, Authorisation and restriction of Chemicals.

What does REACH Regulation set?

REACH sets up the procedures for the compilation and evaluation of all data related to the properties and hazards of chemicals.

Companies can identify their obligations depending on their role and activity. Some of these obligations are described below:

REACH Registration
Safety Data Sheets
Restriction of Substances
Substances subjected to authorisation
Notification of substances contained in articles
Communication in the supply chain (IV Title)

Who is affected by REACH Regulation?

REACH is a cross-regulation affecting – more or less directly – the whole industry, even companies that do not belong to the chemical industry.

Depending on their activity, REACH Regulation sets different roles for the companies:

Manufacturer – company that produces a chemical substance for its private use or intended to be used by third parties.
Importer – company that introduces a chemical substance to the European Union or EEA (European Economic Area) as itself or inside a mixture.
Downstream user – company that uses chemical products without being a manufacturer nor an importer. Downstream users must check their obligations regarding the manipulation of any chemical product.
Only Representative – Natural person or legal entity established in the EEA and appointed by a non-EU company as its Only Representative according to REACH, with the aim of complying all obligations related to the importer role.
Articles provider – Manufacturers or importers of articles, downstream users, distributors or other agents implied in the supply chain that commercialise an article.
Distributor – company whose only activity resides in the storage and commercialisation of chemical substances or mixtures without using them in any way.

If you want to know which roles apply to your company and therefore which obligations you must accomplish do not hesitate to ask us at [email protected]