INTERNATIONAL SCIENTIFIC AND REGULATORY SUPPORT
- EU and UK REACH Support
- European Cosmetics Regulation
- CLP
- Endocrine Disruptors in Europe
- Health Canada and PMRA
EU and UK REACH Support
Achieving and maintaining compliance with the European Union’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation is essential for companies manufacturing or importing chemical substances into the EU or UK. toXcel International helps clients successfully navigate REACH (EC 1907/2006) and UK REACH requirements—reducing regulatory risk, expediting registration, and ensuring market access.
REACH compliance is required for substances manufactured or imported at quantities above 1 tonne/ year. Testing requirements increase with tonnage band and address the intrinsic physical/ chemical, human and environmental toxicity properties of the substance. A separate but similar system operates in the UK. toXcel International is available to help companies navigate the EU and UK chemical substance regulations. toXcel can also help you with testing proposals and the placement, monitoring and reporting of studies required by ECHA, and the evaluation of data for hazard classification.
With a UK-based office and decades of global regulatory experience, toXcel provides practical, strategic support for REACHregistration and post-registration needs.
We offer the following services:
- Only-representative for non-UK manufacturer (we can recommend suitable persons based in the EU)
- SIEF or consortium representation
- Data compensation validation and negotiation
- Data gap analysis (the data requirements vary according to tonnage)
- Literature searches to fill data gaps
- Guidance on the requirements for substance sameness—review of data for acceptability
- Support for joint registrants—completing IUCLID 1-3 (and other sections as required) and actual submission to ECHA via REACH-IT
- Registration after care. Responding to questions from ECHA, placement and management of toxicology studies, dossier updates
- Classification and labelling issues
- We work closely with a number of laboratories in the EU and India to address client data needs.
Whether you’re preparing an initial registration or maintaining compliance, toXcel provides responsive, expert guidance tailored to your product and business model.
European Cosmetics Regulation
To legally place a cosmetic product on the EU market, companies must comply with the European Cosmetic Products Regulation (EC) No. 1223/2009, which mandates a Cosmetic Product Safety Report (CPSR) as a core requirement. toXcel International helps companies meet these obligations by preparing scientifically robust CPSRs that ensure regulatory compliance and consumer safety.
The safety of a cosmetic is assessed based on the known properties of its ingredients. toXcel provides literature-based hazard assessments and reviews suppliers specifications and data, taking into account any impurities. Our overall assessment is based on the properties of the product and anticipated human exposure. The stability, microbial quality, packaging, and labelling are also taken into consideration. The report must be signed by a suitably qualified person; toXcel scientists include Registered Toxicologists (DABT, ERT) and Chartered Biologists (CBiol).
With hundreds of successful CPSRs completed, toXcel provides reliable, efficient support to help your cosmetic products gain and maintain market access in the European Union.
CLP
Proper classification and labeling of chemical substances and mixtures is essential for market access, usersafety, and regulatory compliance in the European Union (EU).
Safety Data Sheets (SDS) in the EU must be based on a classification conforming to (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation) and the formatting and content must follow the description given in (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). CLP implements the Globally Harmonised System (GHS) of classification in the EU; similar legislation operates in the USA, Canada, Brazil, Australia and China. CLP requires all importers, manufacturers and downstream users to classify, label and package substances and mixtures adequately before they can be placed on the market.
toXcel is available to help your company comply with the CLP Regulation for your chemicals and mixtures:
- Classify your substance or mixture according to the principles of GHS;
- Ensure your SDS is compliant with CLP and REACH requirements;
- Where appropriate, apply for an ‘alternative name’ for proprietary substances.
Endocrine Disruptors in Europe
Endocrine-disrupting chemicals (EDCs) are increasingly prioritized under European Union (EU) regulations due to their potential to interfere with hormonal systems and cause adverse health and environmental effects. The EU is actively strengthening requirements under REACH and CLP to identify, classify, and restrict substances with endocrine-disrupting properties.
toXcel International is monitoring this evolving regulatory landscape and is ready to support companies in meeting new compliance obligations and minimizing business risks.
Key regulatory updates include:
- New EU hazard classes for endocrine disruptors under the CLP Regulation (EC) No. 1272/2008)
- Mandatory classification for EDCs:
- For substances: effective 1 May 2025
- For mixtures: effective 1 May 2026
Health Canada and PMRA
Successfully navigating Canadian pesticide regulations requires a deep understanding of the Pest Control Products Act (PCPA) and Health Canada’s Pest Management Regulatory Agency (PMRA) review process. toXcel supports clients in preparing scientifically sound regulatory submissions to PMRA—helping bring pesticide products to the Canadian market efficiently and compliantly.
PMRA only registers pesticide products that demonstrate both acceptable human health and environmental risk profiles and proven value (efficacy) in their intended use. Unlike the US EPA, which generally only requires efficacy data for public health pests, PMRA mandates value/ efficacy data for all products. A registration is typically granted for a term of 5 years, then subject to renewal (however, a registration term can be less than 5 years if it is determined that the risks or value should be reviewed after a shorter period).
While toXcel cannot act as a Canadian agent, we have partners available in-country to act as agent for submissions or toXcel can prepare submission documentation and the PRZ electronic submission files for clients with a legal presence in Canada.
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The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) in the UK and EU
The last of the REACH tonnage bands has passed – but there is still work to do! ECHA continue to evaluate dossiers and issue decisions on additional testing and further data requirements…
To compile a compliant Safety Data Sheet (SDS) in the EU, two main regulations need to be taken into account: Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures (CLP Regulation)…
The EU Cosmetic Regulation Scientific and Regulatory Support
The Cosmetic Regulation (EC) No 1223/2009 came into force across the EU in July 2013. Whilst retaining much of the old Directive, the new Regulation is more specific about the contents of the Cosmetic Product Safety Report, product labelling, appropriate claims and the need to retain a Product Information File…
Pharmaceutical Services Europe
A well planned regulatory strategy is essential to ensuring the best outcome for your product in the European market. Each product is unique and has its own strategic path to get from the manufacturer to market. Pivotal to this is a well-structures non-clinical safety program where information and timing can be critical to each stage of development…