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“Any person who knows all the answers most likely misunderstood the questions.” ~ Dr. Joyce Knudsen

After reading and analyzing a consize article on EurActiv about that issue, I decided to draw the general public’s interest to the significance of the REACH regulation. I hope that this short summary can serve as a thought starter for REACH professionals and REACH specialists, and I am very keen on public and private reactions and comments.

Five years after the adoption of the controversial REACH regulation (Registration, Evaluation, Authorisation and Restriction of Dangerous Chemicals EC/1907/2006 Regulation, hereinafter referred to as the REACH regulation) the revision and the potential modification of this important regulation is on the top of the EU’s agenda. The REACH regulation concerns mainly the (dangerous) chemical substances and I intend to present it’s main characteristics in a nutshell.

A few words about the role of the European chemical industry

In my opinion, the chemical industry notably contributed to the industrial revolution. I do not exaggerate when I say that the chemical industry revolutionized our everyday life, since ex. plastics and another artifical substances controbute to the development of the science and most of the inventions (mobile phones, computers, industrial robots etc.) could not be imaginable without a highly developed chemical industry.

The European chemical industry is the third biggest economic sector of the EU’s industry: the EU produces 31% of the World’s chemicals, more than the U.S. (28 %). The chemical sector created cca. 1,700.000 jobs and it is responsible for the indirect employment of 3.000.000.- people in Europe.

Dangerous chemicals from environmental point of view

Chemicals can be dangerous if they are not used properly (see the example of the frequent acid rains in the XXth century). However, the chemical industry can also effectively help the fight against climate change, since through research and development, new, safer and environmentally friendlier substances can be discovered.

Dangerous chemicals from economic point of view

Dangerous Chemicals and the REACH regulation have a strong economic dimension, as well. The REACH regulation lays down bindig rules for the companies belonging to the chemical industry, and especially under the critical effects of the financial crisis, the economic viability of the chemical sector is crucial. A strong European chemical industry can help Europe to create more workplaces and boost the struggling economy.

A few words about REACH

The adoption of REACH was one of the biggest challenges of the EU at the end of 2006. The main subject of the REACH regulation is the protection of environment and health but it significantly contributes to the economic vialbility of the chemical companies which are prtly SMEs.

Registration (Reach)

From a legal point of view,
the REACH regulation collected several different pieces of the chemical legislation into one single legal act. Furthermore, the REACH regulation introduced a new approach concerning the authorization of dangerous substances. In the past, the authorization of the substances was mainly the responsibility of the national authorities but after the adoption of the REACH regulation, it was up to the industry to register every single existing and new substances.

After the adoption of the REACH regulation, the EU created a lot of other legislations concerning dangerous chemicals (ex. CLP regulation, PPP regulation, Biocide regulation, etc.). Obviously, the European legislator tried to harmonize the content of those new laws with the existing REACH approach as much as possible. However, the chemical legislation is still fragmented, and the REACH regulation does not completly unify the European chemical legislation.

Evaluation (rEach)

The REACH regulation entered into force gradually starting from the 1st June 2007, and a common work and co-operation has been started among the industry, the NGOs, the national authorities and the European institutions. The common evaluation of the chemical substances is a challenging goal that is why the REACH regulation set up the Helsinki based European Chemicals Agency (ECHA) which is a technical body intending to help adressing those challenges.

Authorisation and Restrictions of dangerous chemicals (reACH)

Last but not least, the protection of the high level of health and environment is one of the most important goal of the REACH regulation, based on the precautionary principle. Therefore, the new approach still envisages restrictions and even authorisation for the most dangerous chemical substances, in order to find appropriate alternatives where they exist.

What is the stay of play now and why is the REACH regulation in focus?

After presenting the basic meaning of Registration, Evaluation, Restriction and Authorization in the ‘REACH’ acronym, let’s have a look on the actual situation.

The so-called REACH-project started after the adoption of the new regulation at the end of 2006. The REACH regulation touched upon the core interests of several important Member States, companies and other consumer protection and environmental protection organisations. Thus, the interested parties were not 100% satisfied with the end result and they wanted to change the legal text for their purposes as soon as possible.

At the early periode of the new REACH system, there was no possibility to change the REACH regulation since there was a need for more time to further evaluate the effects, and even the text of REACH itself projected an overall overview of the Regulation 5 years after it’s adoption.

And here is the point. The five long years have been passed, the necessary data and experiences are already collected and every eyes are now on the Commission. All interested parties, companies and NGOs, national authorites and professional organizations are waiting for the next COM proposal. That is why the REACH regulation is in the center of interests and referring back to my starter remarks that is why the time has came to draw the general public’s interests to the importance of the revision of REACH.

The particular example of Substances of very High Concerns (SVHCs)

Finally, in order to help facilitate the ongoing debates, I decided the give a special and actual example. Although there are other interesting and politically heated debates such as the controversial effects of REACH in different Member States, I try to focus on another, more general subject which equally concerns every European stakeholders: the issue of SVHC substances.

“Article 57

Substances to be included in Annex XIV

The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
(a) substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
(b) substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
(c) substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
(d) substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XIII of this Regulation; (e) substances which are very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII of this Regulation;
(f) substances – such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or
(e) – for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other substances listed in points (a) to (e) and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.”

Politically, one of the most important benefit of the REACH regulation is the higher level of safety, especially from environmental and health point of view. Therefore, there is a real need to demonstrate that improvement.

However, the identification of those dangerous substances did not work as quickly as it was projected. The famous Annex XIV does not contain the required high number of the most dangerous SVHC substances defined by article 57 of REACH. Therefore, there is a high pressure on the Commission to show some progress.

Hence, the Commission and ECHA shall take every necessary steps to accelerate that process so that the number of SVHC substances be included into Annex XIV.

The industry need to make appropriate legal and business decisions to meet those criteria. This task will need an effective co-operation among the companies. Since SVHC substances cannot be replaced in every special cases according to the current status of the science, the industry has 2 basic choices to meet the REACH criteria:

1. either to replace the SVHC substances with existing suitable alternatives, or
2. to demonstrate that such substitution is not possible or benefitial (ex. from socio-economic point of view) and the problem of the given SVHC substance can be solved only with appropriate level of protecting measures.

Obviously, COM, ECHA, the Industry, Member States and NGOs can and shall rely on and closely co-operate with each other.

I remain at your disposal.

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Related earlier EU Hemicycle updates:

12. Chemical Coctails and the Way Forward in the Light of the Scientific and Legal Difficulties

Zoltán MASSAY-KOSUBEK

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