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The Reach Regulation (acronym for Registration, Evaluation, Authorization of Chemicals), is the European norm that regulate the discipline of chemical substances.

As the name suggests, it stablishes rules for the registration, the valuation, and the authorization/restriction for all the chemical substances that are produced or imported inside the European territory.

That means that every substance, like paint or clean product, is subject of this regulation.

The aim of the regulation is to ensure protection for human being and environment from the potential negative impact of a particular substance. At the same time, the Regulation states rules to help the European chemistry industry to increase his competitiveness.

The idea behind the Reach is in fact to encourage companies to invest in sustainable innovation, and to do that it uses economic factor. In this moment, many of the substances used in Europe are potentially dangerous; to stem this occurrence, Reach imposes on companies the burden of proof to demonstrate that the use of those substances is safe. That means that companies must work on it, investing high resources in research for a safe use of substances that eventually will be banned in the future.

This fact pushes companies to consider investments in sustainable innovations: the cost may be higher, but it will be more profitable in the future, because the company will be one or more steps beyond other companies. In addition to that, the use of dangerous substances can imply higher taxes and sanctions.

The necessity of a regulation like this relies, as said, in the great amount of use of dangerous substances. In Europe, in the period 2007-2016 930 million of tons of substances have been produced. Of course, not all of them are dangerous, but is estimated that the use of at least 70% of those substances can have potentially dangerous consequences. On the 31 of May 2018, last day for the presentation by producers and importers of the dossiers about chemical substances already on the market, there were 90.000 dossiers presented, for more than 21.000 substances. With numbers like this, it is understandable the necessity to regulate the use of those substances, and to steer this sector into a virtuous direction.

The Regulation has indicated a new authority, the ECHA (European Chemicals Agency) based in Helsinki, who supervise the respect of the Regulation and helps the companies to comply with it. ECHA guides companies to use safer substances: for example, it organizes seminaries dedicated to supply chain, for the promotion of research for safer substances.

In addition, every member state must indicate a national authority who also supervise the application of the Regulation in the state. All the National Authority collaborate and share information each other, to coordinate supervise activity.

In Italy, the national authority is the Ministry of Health, who works with ISPRA (Istituto Superiore per la Protezione e Ricerca Ambientale). They work together to decide if the risks related to the use of a particular substance is not acceptable; in this case, they decide to forbid the substance, or limit the use, or give a the authorization to the user.

The number of addressees of the Regulation is wide: as we said before, the Regulation regards all the substances, and because of it there are many potential actors involved.

The Reach contemplate the following figures:

1. the producer, who produce the chemical substance in order to sell it; he must always comply with Reach.
2. the importer, regardless if he imports the substance itself, or a compound, or also a final product that contains one of the substances;
3. the users, like painters or cleaners as we said at the beginning; if a company use one a chemical substance for its activity, it must check if it is compliant with Reach.

In addiction to those figures the Regulation specify that extra UE companies are not subject of the Reach, even if they sell substances to EU importers, because the duty relies on them.

How does the Reach work in concrete? First, there is the phase of the preliminary registration. This phase relies upon the principle “one substance, one registration”: companies must collect all the information linked to the substance they are using/importing. The duty starts if the amount of the substance is equal or higher than 1 ton per year.

In this case, companies must send the information (dossier) to ECHA. They shall also attach a document of risk assessment if it is necessary. The registration implies the payment of a fee, which is different case by case. For example, fees for SVHC (Substances of Very High Concern) goes from 5.000€ to 55.000€: like we said, the higher the potential damages, the higher fee, to stimulate companies to use non-dangerous substances.

The following step is the valuation from ECHA. This phase is divided in 3 stages:

1. valuation;
2. decision;
3. follow-up.

In the first one, there is a particular process about proposes of experimentation. The attached IX and X to Reach, in fact, list several procedures of experimentation that companies can follow to experiment the use of a substance; if the company decides to try one of those, ECHA must decide if it is good (to avoid useless experimentation on animals). Until the decision, companies cannot proceed with the experimentation.

In the second stage, ECHA write down a project of decision, that is sent to registrants; they can reply with their observations in 30 days. Then, because it is necessary to have the unanimity of all member states, the project (including the observations) is sent to all EU members. They can suggest modifications in 30 days.

If there is any modification suggests, ECHA can adopt the decision; instead, project is sent to member state committee. Also in this case, there must be unanimity for the approving of the project; if not, the case is submitted to EU Commission, that will give the final decision. In this case, registrants must present a new updated dossier, in a within deadline decided by Commission.

This leads to the third phase: expired this time limit, ECHA starts the follow-up, informing eMSCA of the updated dossier. eMSCA evaluates if the updates meet all requirements of ECHA decision, and if the issues with information are solved.

After that, there is a time limit of 12 months to end the valuation phase. If the issue is still pending, eMSCA prepares a new project, asking again for new information. If the issue cannot be resolved, eMSCA may ask for measures to steer down the risks of the substances, like identification of worrying substances, obligation of classification and labeling.

The phase of authorization is the phase where the efforts of the Reach to put users on a sustainable way are more concrete. It starts when a member state or ECHA (by request by Commission), proposes to include a substance in the list of SHVC. SHVC are substances that can be carcinogenic, mutagenic, or toxic for reproduction, that are persistent, bioaccumulative, or toxic (as defined by attached XIII). The process of identification last 45 days. When a substance is indicated as SHVC, producers and importers must comply with some obligation, like provide a security information sheet.

The last phase is about restriction. As before, it starts when a member state or the ECHA ask for it, when there is great concern about a substance.

For the decision of application of restriction, information needed regards identity of substance, motivations for the restriction, identified risks, and a valuation cost-benefit for human health and environment. The dossiers containing all information must be presented to ECHA in the limit period of 12 months starting from notification of intention to start the procedure.

At this point ECHA’s committees valuates if the proposal respects the requirements set by attached XV, and then the dossier is published, to give the opportunity to everyone who is interested to study it and submit observations.

In 9 months from the publication of the dossier, the committee for risks assessment elaborate his opinion about the restrictions. Meanwhile, the committee for socio-economic analysis (SAEC) elaborate its opinion for socioeconomics impacts of the restrictions.

There are 60 days after publication to present comments on this opinion. Then, in 12 months from the first consultation, SAEC will adopt his final decision. The final decision is binding for the industry.

In conclusion, the Reach is the tool used by UE to encourage the transition to the “Green Chemistry”, in compliance with the ecologic policy. This sector is one of the most important in the process of protection on environment, in which new and alternative technologies are necessary and potentially highly advantageous in the future. Companies must be encouraged to invest in new tools and substances, to increase their value and help protect our planet at he same time.

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