REACH Regulation
Comprehensive solutions for registration, evaluation, authorisation and restriction of chemical substances in Europe.
REACH Regulatory Services
Protecting sustainability, competitiveness and innovation
REACH is Regulation EC 1907/2006 concerning the registration, evaluation, authorisation and restriction of chemical substances and preparations. The REACH Regulation aims to improve the protection of human health and the environment while maintaining the competitiveness and innovation of the EU chemical industry.
REACH Monitor has successfully prepared substance registration dossiers for sectors as diverse as pharmaceuticals, additives, lubricants, sealants, antioxidants, fragrances, pigments, petrochemicals, gases, commodities, and more.
REACH Monitor offers a comprehensive service for REACH compliance: technical and management assistance, as well as R&D projects to optimise your resources throughout the REACH processes.
We are happy to help you with anything from a single question to the full compilation of your dossier.
Our REACH Services
Complete solutions for every stage of the regulatory process
REACH Registration Process
REACH Diagnosis
We analyse the best registration strategy for your company and conduct an internal audit to determine your specific obligations under the REACH Regulation.
Dossier Preparation
We manage all technical phases: pre-inquiry, substance identification and similarity, testing strategy, toxicological assessment, QSAR modelling, read-across approaches, and compilation of technical dossiers (IUCLID).
Submission to ECHA
We manage the submission via REACH-IT, provide assistance during the completeness check, and offer post-submission support in communications with ECHA.
Ongoing Assistance
We provide continuous post-registration support, including adaptation to potential regulatory changes and solutions for the post-Brexit market.
Analytical Identification
We precisely determine the chemical composition and identity of your substances according to ECHA requirements.
QSAR Modelling
We use advanced computational models to predict toxicological properties and reduce the need for testing.
Risk Assessment
We perform comprehensive risk assessments for human health and the environment according to ECHA-approved methodologies.
Dossier Evaluation
ECHA examines registration dossiers to verify that the information meets legal requirements. We provide support throughout the compliance check process.
- Preventive analysis of potential non-compliances
- Response to ECHA requests
- Update of information according to new requirements
Substance Evaluation (CoRAP)
Member States evaluate substances that may be of concern. We help companies respond effectively to these evaluations.
- PBT/vPvB substances
- Endocrine disruptors
- CMR substances (carcinogenic, mutagenic or toxic for reproduction)
Response Strategy
REACH Monitor helps companies find the most appropriate strategy to respond to authority requests.
- Submission of additional information
- Scientific argumentation of positions
- Coordination with other registrants
Authorisation is a procedure aimed at ensuring that the risks from substances of very high concern (SVHC) are either adequately controlled through appropriate risk management measures (RMM) and operating conditions (OC), or that these substances are progressively substituted by suitable alternatives.
Any substance included in the authorisation list (Annex XIV) may only be placed on the market or used if authorisation has been granted for a specific use, or if the use has been exempted from the authorisation requirement.
SVHC Monitoring
We continuously monitor the candidate list of substances of very high concern to anticipate potential impacts on your business.
Alternatives Analysis
We research and evaluate possible alternatives to SVHC substances, considering technical, economic and safety aspects.
Socioeconomic Analysis
We develop robust socioeconomic analyses demonstrating the justification for the continued use of substances subject to authorisation.
Risk Re-evaluation
We perform comprehensive re-evaluations of environmental and human health risks, demonstrating adequate control or minimisation of risks.
REACH may apply restrictions to substances where there is an unacceptable risk to human health or the environment arising from the manufacture, use or placing on the market of those substances.
A substance for which Annex XVII of REACH contains a restriction may not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
Regulatory Monitoring
We continuously monitor proposed restrictions that could affect your products or processes.
Participation in Consultations
We help you prepare effective responses during public consultation periods on proposed restrictions.
Process Adaptation
We develop strategies to adapt your processes and products to new restrictions.
Search for Alternatives
We identify and evaluate viable alternatives for restricted substances or substances undergoing restriction.
REACH Monitor helps companies develop a strategy to anticipate and/or address the restriction process best suited to their specific needs.
Companies that have completed their registrations must keep the information up to date to reflect not only the correct volume of production or importation, composition, properties or new uses of the substance, but also new requirements that ECHA implements over time.
It should be noted that this update is not just good practice, but also a legal requirement.
Information Update
We keep your dossiers updated with changes in volumes, composition, properties and uses of your substances.
New ECHA Requirements
We implement the necessary updates to comply with new ECHA requirements.
- New completeness check
- Boundary composition
- Nanomaterials
Continuous Monitoring
We constantly monitor your regulatory obligations and notify you of relevant changes.
- Substances included in evaluation processes (CoRAP, CLH proposal, etc.)
- New entries on the authorisation list (Annex XIV)
- New entries on the restriction list (Annex XVII)
REACH Monitor will check all regulatory changes affecting your company. We contact you whenever your chemicals are impacted. We do not send generic newsletters, but we will always inform you if there are changes affecting your company or substance.
REACH Monitor has been supporting many international consortia and individual registrants since 2008. REACH Monitor handles management responsibilities from the perspective of a full-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 entire team has extensive experience managing the following activities:
Consortium Formation
We organise and manage consortia to share data and costs among multiple companies, optimising resources and ensuring regulatory compliance.
Joint Registration and SIEF
We coordinate joint registration submissions and facilitate effective collaboration within Substance Information Exchange Forums (SIEF).
Data Sharing
We negotiate data sharing agreements between companies, ensuring fair, transparent and non-discriminatory conditions.
Only Representative
We act as Only Representative for non-European manufacturers, fulfilling all regulatory obligations on your behalf.
Third-Party Representative
We offer third-party representative services to protect confidential business information during registration and collaboration processes.
R&D Service
Research and Development to Optimise Your Processes
Our research experience allows our team to quickly understand your innovative projects. We can design and establish R&D+i lines for your company.
Experimental Design
We develop protocols for experimental tests tailored to the specific needs of your company and sector.
Substance Substitution
We propose alternatives for carcinogenic, mutagenic, toxic for reproduction, endocrine disrupting and PBT/vPvB substances.
Process Optimisation
We evaluate your processes to improve outcomes in exposure scenarios and mitigate risks.
Computational Simulations
We carry out simulations and advanced calculations to predict toxicological and ecotoxicological properties, as well as environmental and human exposures.
Our experienced team of experts in toxicology, ecotoxicology and chemistry has worked on numerous innovative projects, providing companies with the best strategy for their substances with a global perspective to face future challenges.
Frequently Asked Questions about REACH
Answers to the most common questions about chemical regulation
Who must register substances under REACH?
All companies that manufacture or import substances in quantities equal to or greater than 1 tonne per year must register. For imported mixtures, this threshold applies to each individual component. Manufacturers established outside the EU may designate an Only Representative to fulfil these obligations.
When is it necessary to update a REACH registration?
Registrations must be updated when there are changes in: production/import tonnage, substance composition, newly identified uses, new hazard knowledge, changes in classification and labelling, changes in company information, or when there are new requirements implemented by ECHA. Updating is not only good practice, but a legal requirement.
What is an SVHC substance and what does it imply?
Substances of Very High Concern (SVHC) are those that may have serious effects on human health or the environment. They include CMR substances (carcinogenic, mutagenic or toxic for reproduction), PBT (persistent, bioaccumulative and toxic), vPvB (very persistent and very bioaccumulative) and endocrine disruptors. SVHCs may be included on the candidate list and eventually in Annex XIV, which requires authorisation for their use.
How does Brexit affect REACH compliance?
Following Brexit, the United Kingdom has established its own regulatory system (UK REACH), independent of EU REACH. Companies placing substances on the market in both the EU and UK must comply with both regulations. REACH Monitor offers specialised UK REACH services through REACH Monitor UK, to ensure continued access to the British market.
What are QSAR models and how do they reduce costs?
QSAR (Quantitative Structure-Activity Relationship) models are computational tools that predict toxicological and ecotoxicological properties of substances based on their chemical structure. These models can significantly reduce the need for animal testing and lower costs, provided they are used following ECHA guidelines to ensure valid and reliable predictions.