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Editor-in-chief: Maurizio Roncaccia

Editor: Paul Trouth

Article related to: REACH

What happens with potential chemicals of concern?

Thanks to REACH and CLP, the amount of information available on chemicals is increasing. As a result, chemicals of potential concern can be better identified. But what do we do when our scientists suspect that a chemical may be of concern, but there is insufficient data to make a judgement? How do we manage the risks?

Focusing on substances that matter the most

Among all substances, ECHA, the Member States and the European Commission have agreed to prioritise those of potential concern where the impact on human health and the environment is the greatest. Together, we also identify the most effective way of confirming and addressing concerns. Priority is given to substances that have the highest exposure potential combined with their potentially hazardous properties, for example, substances that are carcinogenic, mutagenic and toxic to reproduction (CMR); persistent, bioaccumulative and toxic/very persistent, very bioaccumulative (PBT/vPvB) or endocrine disruptors.

This approach (we call it our integrated regulatory strategy) brings together all REACH and CLP processes in a coherent way and contributes to meeting the 2020 goals of the World Summit on Sustainable Development.

Screening to find potentially hazardous substances

One central element of the strategy is the common screening. It integrates how substances are prioritised and selected for different risk management measures under REACH and CLP.

ECHA maintains the largest database on chemicals in the world with information on more than 120 000 chemicals. It is the main source of data for screening that aims to identify substances that matter the most.

Therefore, it is vital that registrants keep their dossiers up-to-date so that information on hazards and also uses, tonnages and conditions of use in the database is correct. If the information in registration dossiers is not up-to-date, authorities may target regulatory measures at the wrong substances.

The screening now looks at groups of substances with similar hazardous properties. This allows well informed decisions to be made on a higher number of substances in a shorter period than if they were examined one-by-one.

Registrants are informed if their substance has been identified as being of potential concern during the screening. If more data is needed to conclude whether the substance is of concern or not and the registrants are not complementing the data on their own initiative, then we can opt for a compliance check of the dossier, or suggest that the substance is evaluated as a whole, taking into account all the data from dossiers for that substance.

Generating further information

During a compliance check, ECHA ensures that the registration dossier complies with the standard information requirements of REACH. If it does not, the registrant must submit the missing information, which could mean carrying out new tests, by a specified deadline.

Compliance checks mainly focus on eight hazard properties – genotoxicity, repeated-dose toxicity, pre-natal developmental toxicity, reproduction toxicity, carcinogenicity, long-term aquatic toxicity, biodegradation and bioaccumulation. We focus on these properties because they are the most crucial for protecting human health and the environment.

To help companies and stakeholders see which substances are being worked on, we publish a list of substances that may be subject to compliance check. This list is updated several times a year and announced in our weekly news bulletin.

There are other ways of generating data too – for example by evaluating the substance as a whole. Substances are selected according to risk-based criteria. Again, the aim is to detect those substances that are of greatest concern. Companies and stakeholders can see which substances Member States are going to look at in the Community rolling action plan (CoRAP). The CoRAP also indicates which Member State will conduct the evaluation.

During substance evaluation, Member States look at all the data, including the information in registration dossiers, to see if using the substance poses a risk to human health or the environment. In this case, registrants may have to send additional information or perform tests also beyond the standard registration requirements for REACH. Based on the additional information provided, Member States may conclude that risk management measures are needed.

Choosing the best option to manage the risks

Once a concern has been identified and confirmed, ECHA and the Member States analyse the different risk management options for a particular substance or group of substances.

There are several regulatory risk management options available under REACH and CLP, i.e. harmonising the classification and labelling of the substance, requiring its use to be authorised, or restricting its placing on the market or use.

A risk management option analysis (RMOA) can also conclude that no risk management measures are needed at that time. This could be the case, for example, where the identified concern is found to be already addressed under another piece of EU legislation.

The substances for which ECHA and the Member States are considering the best risk management option can be found in the Public Activities Coordination Tool (PACT) on ECHA’s website. This list is useful for many stakeholders. Those companies using a listed substance can start thinking if it is possible to replace it with a safer alternative. Those companies having an alternative to a listed substance can further plan how to market it. It also gives companies and concerned citizens more time to prepare their input for the public consultation on the substance, which runs during the formal risk management processes.

Regulatory risk management

Substances that fulfil the criteria for carcinogenicity, mutagenicity, reproductive toxicity (CMR) or respiratory sensitisation, should normally be subject to harmonised classification and labelling (CLH). The classification is legally binding for all suppliers who place the substance on the EU market – on its own or in mixtures.

Sometimes companies have a strong reason to continue using substances of very high concern (SVHCs). However, these substances are prime candidates for being made subject to authorisation, particularly if they are widely used. If these substances are placed on the Authorisation List, their use requires a specific permission from the European Commission.

Substances with harmonised classifications are considered SVHCs. These include those categorised as CMR 1A (known carcinogens based on human evidence) or 1B (presumed carcinogens based on animal studies); persistent, bioaccumulative or toxic (PBT); very persistent, very bioaccumulative (vPvB), or substances of equivalent level of concern to these, for example, due to endocrine-disrupting properties.

If a chemical poses an unacceptable risk that needs to be addressed at EU level, a restriction on the manufacture, placing on the market and/or uses of the substance of concern may be proposed by a Member State or ECHA, at the request of the Commission.

The Registry of Intentions includes all notifications of intention to submit a harmonised classification and labelling, SVHC identification or restriction dossier. The notification is done by a Member State or ECHA, at the request of the European Commission. It is updated regularly and gives stakeholders time to prepare their comments for upcoming public consultations for which an intention is registered.

Regulatory process	Where to find information?
Compliance check	List of substances potentially subject to CCH
Substance evaluation	CoRAP list
PBT/vPvB assessment ED assessment RMOA	Public Activities Coordination Tool (PACT)
CLH/SVHC identification/ Restriction intentions and proposals	Registry of Intentions
Substances with harmonised classification and labelling	Table of harmonised entries in Annex VI to CLP
Substances of very high concern	Candidate List Authorisation List
Restricted substances	Restriction List
Where to find information on your substance within different regulatory processes.

Flowchart to show how activities and processes are linked

A representation of how activities and processes are linked. Substances might also enter these processes or activities at any point in time, without strictly following this flow. Image: ECHA.

ECHA's aim in managing potential chemicals of concern

To efficiently select substances that raise potential concerns. This often requires generating further information to assess their safety so that any remaining concerns can subsequently be addressed through the most suitable risk management measure.
To make the outcomes of the evaluation and risk management processes more transparent for stakeholders and registrants.
To ensure that the different actors (industry, NGOs and authorities - Member States, the European Commission, ECHA) can intervene in an appropriate and timely way so that chemicals of concern are addressed as soon as possible.

Further information:

ECHA’s integrated regulatory strategy

Addressing chemicals of concern

Annual reports: SVHC Roadmap to 2020 implementation