REACH

REACH stands for Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals. The REACH Regulation aims to improve the protection of human health and the environment while maintaining the competitiveness and innovation of the EU chemicals industry.

REACH Monitor prepared successfully registration dossiers for substances of very diverse market sectors such as pharma, additives, lubricants, sealants, antioxidants, fragrances, pigments, petrochemicals, gases, commodities, etc.

REACH Monitor offers a comprehensive service for REACH compliance: technical and management assistance as well as R+D projects to optimise your resources at REACH processes.

We will be happy to assist you from a single question to the full dossier compilation.

Reach

REGISTRATION

If you manufacture or import 1 tonne or more per year you need to register your substance. For imported mixtures, this threshold applies to every single component. Bear in mind that the registration shall be kept up to date. [link keep up to date].

REACH Monitor can help your company not only for the technical part but also in the management.

REGULATORY SERVICES:

Diagnostic on the application of REACH for your company

Analysis of the best registration strategy
Internal auditing

Dossier preparation

Inquiry
Analytical identification and sameness of the substance
Data gap analysis and intelligent testing strategy
Study monitoring
Data waiving rationale
QSAR modelling
Read-across approaches
Evaluation of the toxicological and ecotoxicological profile
PBT/vPvB assessment
Risk assessment
Endocrine Disruptor (ED) assessment
Strictly control conditions (SCC) report for intermediates
Technical dossier compilation (IUCLID)

Dossier submission to ECHA (REACH IT)

Assistance on the completeness check
Post-submission assistance, communication with ECHA

Assistance during an enforcement

Brexit

MANAGEMENT SERVICES:

REACH Monitor is giving support to many international Consortiums and individual lead registrants, since 2008. REACH Monitor deals with management responsibilities from the perspective of a global service provider.

Your project will be assigned to a specific manager, permanently assisted by our team of technicians and scientists in the fields of toxicology, ecotoxicology and chemistry. The whole team has extensive experience in managing the following activities:

Formation of consortia and assistance to their members
Joint submission and SIEF
Data sharing negotiations
Only representative
Third party representative

EVALUATION

ECHA examines the registration dossiers to verify that the information in them is compliant with the legal requirements and the Member States evaluate substances that may be of concern to clarify if they could constitute a risk to human health or the environment.

Evaluation processes under REACH:

Dossier evaluation (Compliance check)
Substance evaluation (Community Rolling Action Plan, CoRAP):
- PBT/vPvB substances
- Endocrine disruptors
- CMR substances (carcinogenic, mutagenic or toxic to reproduction)

After these evaluations, registrants may be required to submit further information on the substance.

REACH Monitor assists companies in finding the strategy to give the most appropriate response to the authorities’ requirements to meet the regulatory requirements.

AUTHORISATION

Authorisation is a procedure that aims to assure that the risks from substances of very high concern (SVHC) are either properly controlled by appropriate risk management measures (RMM) and operational conditions (OC) or that these substances are progressively replaced by suitable alternatives.

Any substance included in the Authorisation List (Annex XIV) can only be placed on the market or used if an authorisation has been granted for a specific use or the use has been exempted from the authorisation requirement.

REACH Monitor assists companies in developing a strategy to try to anticipate and/or face the authorisation process that best suits their specific necessities.

Surveillance of the candidate list of Substances of Very High Concern
Analysis of alternatives
Socio-economic analysis
Re-assessment of environmental and human health risks

RESTRICTIONS

REACH regulation may set restrictions to substances if there is an unacceptable risk to human health or the environment, arising from the manufacture, use or placing on the market of these substances.

A substance for which Annex XVII of REACH contains a restriction cannot be manufactured, placed on the market or used unless it complies with the conditions of that restriction.

REACH Monitor assists companies in developing a strategy to try to anticipate and/or face the restriction process that best suits their specific necessities.

KEEP YOUR OBLIGATIONS UP TO DATE

The companies that have completed their registrations need to keep the information up to date, to reflect, not only the correct production or import volume, the composition, properties or new uses of the substance but also the new requirements that ECHA implements over time.

It must be borne in mind that this update is not only a good practice but also a legal requirement.

Technical services:

Dossier information update

New ECHA requirements

New completeness checks
Boundary composition
Nanomaterials

Continuous surveillance of your obligations

Updated Notification/Information of new requirements applicable to your chemicals
Tailored monitoring of any new REACH obligations/ duties
Continuous checking of
- Substances included in evaluation processes (coRAP, CLH proposal, etc.)
- New entries in the list of substances subject to authorisation (Annex XIV of REACH regulation) [link]
- New entries in the list of substances subject to restriction (Annex XVII of REACH regulation) [link]

REACH Monitor will check for you all changes on regulation that affects your company. We contact you each time your chemicals are affected. We won’t send you generic newsletters but will always let you know if any changes apply to your company or your substance.

MANAGEMENT SERVICES:

Formation of consortia and assistance to their members [link]
Joint submission and SIEF
Data sharing negotiations
Only representative
Third party representative

R & D

Our background in research allows our team to rapidly understand your innovative projects.

We can design and establish R+D+i lines for your company:

Design of protocols for experimental assays adapted to the needs of your company.
Proposal of alternative substances for the substitution of carcinogenic, mutagenic or toxic substances to reproduction (CMRs), endocrine disruptors, persistent, bio-accumulative and toxic substances (PBTs and vPvBs), etc.
Assessment in the processes to improve the results of the evaluation of Exposure Scenarios.
Computer-based simulations and calculation of new processes.
- Prediction of toxicological and ecotoxicological properties of substances.
- Environment and human health exposures.

Our experienced team of experts in the fields of toxicology, ecotoxicology and chemistry worked in many different innovative projects that aimed to provide companies with the best strategy for their substances with a global perspective to facing future challenges.

RECENT PROJECTS

REACH Monitor has many years of experience in REACH application.

Since 2008, REACH Monitor has conducted the registration of hundreds of substances from many different companies and has assisted them in any part of the whole process of REACH providing the best technical and economical solution, tailored to their necessities and requirements.

TESTIMONIALS