Chemicals

The purpose of this Regulation is to ensure a high level of protection of human health and the environment.
Companies must identify and manage the risks linked to the substances they manufacture and market in the EU in a tonnage > 1 ton/year.

If you make chemicals (even if it is for export) or if you import anything from outside the EU, you will probably have some important responsibilities under REACH.

If you are a company established outside the EU, but you export your products into the EU, you have not the obligations of REACH, but you can appoint an Only Representative in EU.

– Substance identification and Data gap analysis
– Registration dossiers
– Exposure scenarios, Chemical Safety Assessment and Chemical Safety Report documents (CSA/CSR)
– Only Representative appointment
– Consortia Management
– Data sharing agreement and SIP (Substance Information Profile)
– Study monitoring
– Support for Authorisation and Restriction

The CLP Regulation (EC) No1272/2008 aligns previous EU legislation with the GHS (Globally Harmonised System of Classification and Labelling of Chemicals), a United Nations System to identify hazardous chemicals and to inform users about these hazards.
Under CLP Regulation (EC) No 1272/2008 companies supplying chemicals as substances and/or preparations on the EU market, must classify, label and package these products in accordance with the Regulation.

– Hazard Classification and Labelling of substances/mixtures;
– Notification of substances to the Classification and Labelling Inventory;
– Check Labelling requirements for substances/mixtures;
– Preparation and submission of PCN Submission (UFI, EuPCS, single/group/limited submission)

We provide professional services for the generation of Safety Data Sheets (SDS) & Extended Safety Data Sheets (eSDS), fully compliant with EU and US (OSHA) standards.

Our technical translation services include almost all EU languages.
Additional languages may be available on request:

– SDS authoring in most all EU languages (EU and OSHA standards);
– Inclusion of Transport Classification;
– Competent Person appointment;
– Exposure scenarios (ES)

This is the database for information on Substances of Concern In articles as such or in complex objects (Products) established under the Waste Framework Directive (WFD).

Companies supplying articles containing substances of very high concern (SVHCs) on the Candidate List in a concentration above 0.1% weight by weight (w/w) on the EU market have to submit information on these articles to ECHA.

The SCIP database ensures that the information on articles containing Candidate List substances is available throughout the whole lifecycle of products and materials, including at the waste stage. The information in the database is then made available to waste operators and consumers.

– Processes assessment and support
– Analytical investigation
– Report and notification at the SCIP database

The EU’s REACH chemical legislation may attract the most attention, but other regions have also been busily establishing or strengthening their own programs for the regulation of chemicals. We can provide you assistance with a wide range of chemical regulation across the world by supporting you directly or through our commercial partners.

– Proposition 65 (California, USA)
– UK REACH
– China REACH

Toxicology (DEREK Nexus), Genotoxicity (SARAH Nexus), Metabolism (METEOR Nexus) and Degradation Products (ZENETH Nexus)
Interpretation of results and Expert Report by our ERT® (European Registered Toxicologist)

A compliance audit is a series of checks performed to make sure that your Company is meeting the regulatory standards applicable. In other words, it is a way of making sure that all regulatory requirements have been set up.

The checks carried out by an external, impartial party may help to avoid penalties during an institutional verification.

We can assist your Company in the:

– Verification of the REACH management system
– Verification of Strictly Controlled Conditions
– Analysis of the substance’s life cycle and verification of the Exposure Scenarios

We can provide to your Company personalized training courses on the topics you prefer, such as (but not limited to):

– REACH regulation in general
– CLP regulation
– SDS/eSDS management
– New PCN format for notification to Poison Centers
– SCIP database vs IMDS database