REACh

Applicable since 2007, this European regulation has forced the industrial sector to rethink all practices relating to the production, import and use of chemical substances. From the supply of raw materials to relations with competitors, from the production of data on intrinsic properties to their general dissemination: these new rules require new commercial strategies, new behaviour and new responsibilities.
With more than 100 registration dossiers, EquiTox offers you its skills for:

1- The identification of constraints
Analysis of the portfolio and flows of chemicals
Based on the inventory of substances, tonnage readings and purchases/sales flows, a diagnosis of the constraints imposed by REACh will be proposed.
Definition of the registration strategy
As part of your substance registration process, we inform you of the deadlines to be respected, the competitive environment (SIEF) and the costs you may have to bear.
Regulatory status of your Legal Entity
We help you find the role best suited to your situation and development and sourcing strategy (Lead-registrant, Follower, Only-representative, Third party representative etc.).
2- The creation of technical dossiers
Search for and analysis of existing data
The use of existing data reduces costs and lead times. We search for the elements available and analyse them for you from a scientific, regulatory and commercial perspective.
Determination of the registration strategy
With a view to registering your substance and minimising costs, we establish a testing programme and a roadmap for the creation of the registration dossier.
Generation of missing data
We select for you the studies to be conducted in laboratories with the best quality to price ratio. We closely monitor these studies and inform you of key results as soon as they become available for the creation of the registration dossier.
Creation of the technical dossier (IUCLID)
We compile the technical dossier with your collaboration up to acceptance following the Technical Completeness Check (TCC).
Drafting of the Chemical Safety Report (CSR)
We help you identify the uses of your substance, assess health and environmental risks, help you define risk management measures and the operational conditions combining operational realism and the protection of workers and the environment. We write the Chemical Safety Report (CSR) which must feature in the registration dossier.
3- The administrative management of the registration process
Representation within the SIEFs
EquiTox advises you in your relations with competitors and can act as a Third Party Representative, guaranteeing discretion in the market positioning of your products.
Management of your REACh-IT account
We perform all required operations via the REACh-IT interface on your behalf; we monitor the exchanges within your SIEFs and regularly inform you of events relating to your substances in the form of reports.
What to do after the 31 May 2018 ?
It is important to continue the cooperation in the SIEF in order to answer ECHA’s demands in a concerted way. Cooperation between members is essential during the evaluation process. In that perspective, pay attention to the deadline stipulated in the SIEF agreements, it might be necessary to renew these contracts.
4- Necessary update of your files

REACh did not stop on 31 May 2018. A new cycle is taking place with control reinforcement from January 2019, with the aim of accelerating the updates (according to Art. 22 of REACh).

Why updating your dossiers ?
Be proactive in the update of your dossiers, because if you receive a compliance check decision, you must comply, even if the status of your substance has changed (cessation of activity, reduced volumes, complete versus SCC intermediate registration…).
Identification of the key elements to be updated
European authorities are particularly mindful of the dossier compliance, specifically towards the status of the intermediates under strictly controlled conditions, waivings, read-across justifications… We identify in your files the key elements potentially subject to compliance checks to be able to proceed in an efficient update, thus avoiding that you receive a decision.
How to avoid an evaluation process ?
ECHA regularly proceeds to prioritisation within substances to be evaluated (CoRAP). We can help you in the proactive identification of these substances in your portofolio, combining targeted hazards, volumes, uses. The update of your registrations with more relevant data can prevent a prioritisation of your substances.
Management of the substance identification issues
Substance identification is a central concern for ECHA. If you have registered a UVCB, if you have omitted some impurities, provided insufficient proof for the SIEF “sameness”, or if you have included different hazard profiles in the same dossier, then it is likely that ECHA will come to you with questions. EquiTox have successfully built numerous inquiry dossiers for UVCB. This experience is today at your disposal, from discussion about appropriate analyses to the drafting of the composition into IUCLID.
Check of the strictly controlled status (SCC) of your intermediates
In declaring a strictly controlled status, you have benefited from a reduced registration for your intermediates. Enforcement authorities are more and more stringent on this specific issue and multiply the controls. EquiTox have successfully built numerous SCC intermediate dossiers and supported their clients during SCC targeted audits.
5- Evaluation: follow up and compliance
Which follow-up implement in your company?
Highly skilled in the evaluation processes, EquiTox can support you in the implementation of a follow up and an alert system to anticipate the different evaluation processes (testing proposals, compliance checks, CoRAP), to get you organised and be ready to anticipate the impacts of the decision.
Answer to the decision and compliance
No matter the subject of the decision, a testing proposal, a compliance check or a substance evaluation, EquiTox can help you in answering and ensuring the compliance by using all the necessary arguments and expertise to reduce the relative costs (notably by our knowledge of the RAAF – Read Across Assessment Framework).
6- Authorisation – support during the different steps of the process
Substance of Very High Concern identification (SVHC)
The identification of a very high concern substance leads to a plublic consultation. EquiTox helps you to anticipate this consultation, by regularly checking the Register of Intentions. The consultation only lasts 45 days, then it is recommended to prepare before.
Update of the candidate list (SVHC)
If you are a manufacturer/importer or if you provide articles, EquiTox supports you in complying with your obligations of notification to the Agency or with communication to your customers.
Prioritisation by ECHA and annex XIV publication
With its partners, EquiTox can help to build strategies: which are the uses? are you really subject to authorisation? if so, which strategy to adopt: substitution or authorisation request? Individual or grouped submissions? For downstream users, check that your supplier supports your use and otherwise assesses your interest in providing your own application.
Authorisation application – Chemical safety report
EquiTox builds with you the chemical safety report of the authorisation application. In that perspective, EquiTox

  • maps all the uses and the exposure steps
  • helps you in implementing monitoring campaigns
  • builds specific scenarios for health and environment
  • characterises the exposure and the risks for the uses of the application
  • supports you in the communication with the ECHA’s experts of the risk assessment committee
When authorisation is granted
When authorisation is granted to a supplier, downstream users have obligations: notification to ECHA of the first delivery (within 3 months), fulfillment of the authorisation conditions. We support you in these processes and when needed, we propose the necessary measures to ensure the compliance.
7- With our partners
Legal assistance
We introduce you to law firms familiar with the REACh regulation and capable of providing you with specific advice.
Management of your consortia and SIEFs
Our partners help you determine the rules governing consortia and SIEFs, coordinate these entities and manage long-term financial relations between consortium and SIEF members.
Socio-economic analyses and alternatives
Concerning the analyses of the possible alternatives and the socio-economic part of the authorisation application, we collaborate with partners highly skilled in these issues.
8- Case studies
Withdrawal of a draft decision from ECHA concerning a testing proposal
One of our biggest successes was the withdrawal of a draft decision from ECHA concerning a testing proposal. Working within the tight deadline and in coordination with the client (Lead Registrant), we were able to bring the SIEF members together and define a pertinent strategy arguing for the waiver of the required tests. Then we setup a meeting with ECHA’s representatives. Following this, we provided a written and a unanimously agreed response. The outcome was an update of the registration dossier and the approval from ECHA not to perform the requested tests.
REACH registration dossier: when the clock is ticking and the expertise in toxicology is lacking
In preparation of a REACH registration deadline, an SME specialised in organic chemistry for the cosmetics and the food markets launched sub-acute toxicological tests with the advice of a CRO. However, due to a lack of in-house expertise in toxicology, the study design wasn’t appropriate for the chemical specificity of the test substance. As a consequence, the study had to be stopped because of several major deficiencies.

EQUITOX was contacted at that time. The requirements were clear: to produce a registration dossier without missing data, that would pass the technical completeness check and was scientifically robust. All of this needed to be done in a short period of time. The strategy we developed was based on the physico-chemical properties of the substance (hydrolysis) and a read-across approach with well-known degradation products. We then completed with a weight-of-evidence using some information from the abandoned sub-acute toxicological study.

We submitted, on-time, a reliable and valid registration dossier.

Non-Testing Methods (QSARs, Read-Across): When a Trap Becomes Chance
Non-testing methods, such as structural alert profiling, QSARs, read-across, can provide valuable information for regulatory purposes (REACH, Cosmetics, Biocide…) at a reasonable price and with limited resources. However, the way new data is generated and reported must be based on two pillars: good science and a well detailed/documented report.

Indeed, a lot of IT-tools and experimental data are available. However, when making a prediction or an extrapolation, one must go back to the basics: a well-defined endpoint, a robust dataset, an understandable relationship between the data source and the newly generated value/parameter. It takes shape in the assessment of the applicability domain for a QSAR prediction or the adequacy of a database for a read-across (analogy, category approach). Once a reliable value is generated, the second main task is to report it in order to pass the evaluation by Regulatory Bodies. For this purpose, official templates are available meeting the OECD/ECHA principles (QPRF, Read-Across Assessment Framework – RAAF). Thanks to their dual skills (scientific and regulatory), experts from EQUITOX drive the scientific assessment of the data source, the relevance of the prediction/extrapolation and the reporting in a formal way. EQUITOX applies this approach to comply with the REACH registration requirements, especially QSARs for the Annex VII tonnage band (1-10 tons), the read-across justification for any tonnage band. In addition, non-testing methods are used for projects related to the Cosmetics regulation.

Intermediate SCC and extended-SDS: a Link Between Regulatory Dossiers and Real-Life.
One main goal of REACH is to protect workers and the environment from chemical hazards. Two concrete applications of this principle are the assessment of the compliance to the Strictly Controlled Conditions for intermediates (SCC – REACH art. 17(4) and 18(4)) and to the exposure scenarios (ES) summarised in the extended Safety Data Sheets (e-SDS) from suppliers. These compliance checks concern both manufacturers of chemicals and downstream users.

The main difficulty in this type of project is to allow two different worlds to work together, the regulatory experts and the on-site operators (usually the HSE department). EQUITOX benefits from its strong experience in both worlds to support the deployment of these projects in industrial plants.

In a project where 7 intermediates were audited, the compliance with the SCC was demonstrated for 4 chemicals. Therefore, EQUITOX prepared the simplified REACH registration dossiers, and provided the Plant Manager with the relevant documentation. This set of proof justifies the regulatory decision in the case of a control by Local Authorities. In the same way, EQUITOX trained and deployed an efficient methodology to comply with the duties related to the e-SDSs for raw materials (prioritisation, ES conformity, DU CSR, exemption…).

For more information

Keywords: , , , , , , , , , , , , , , , , , , , , , , ,

Print Friendly, PDF & Email