Preparation of IUCLID dossiersOECD Harmonised TemplatesRisk assessmentPoison Centre NotificationsSelling chemical products onlineRegulatory submissions
Ekotox Centers are providing consultancy services and customers support in the area of EU chemicals legislation – REACH Registration, Only Representative, REACH Authorisation, REACH/CLP Screening, Safety Data Sheets, Legal Compliance Services.
Ekotox Centers
- Tel +421 2 45943712
- e-mail on ekotox(at)ekotox.eu
We offer support and preparation of all documents. Required for registration / authorisation of a biocidal product for placing on the market in EU member states.
Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensation
Ekotoxikologické centrum Bratislava, s.r.o. routinely conducts data gap analyses to inform product development and defence strategies, as well as for regulatory submissions. Our specialists provide expertise in evaluating studies, reviewing literature data and addressing requirements using existing information. If required, our experts can address data gaps through placement and monitoring studies, including
- compound physical-chemical properties
- degradation studies e.g., soil, manure, marine water
- soil sorption/desorption studies
- photolysis/hydrolysis studies
- ecotoxicological studies
- kinetic analysis of laboratory and field degradation/dissipation studies to derive regulatory acceptable endpoints.
Regulatory strategy development
Although every regulation presents a fixed list of mandatory data requirements to have to be satisfied, the way in which those requirements can be addressed is dependent on the substance/product in question. Regardless of the regulation all strategy planning follows the same three steps:
- Data Gap Analysis
- Endpoint completion strategies; test programmes for phys-chem, analytical, toxicity, ecotoxicity, environmental fate, efficacy for biocides or alternative waiving arguments.
- Regulatory strategy and the impact on the endpoint completion strategy, e.g. REACH tonnage triggers or biocidal product families and authorisation types.
Every situation is different and therefore our personalised regulatory strategy service is tailored to your individual needs.
Project management and study monitoring
Where a testing programme to fulfil the regulatory requirements has been identified, we are about to assist companies with study monitoring.
This service includes:
- obtaining quotations and assistance on choosing a testing facility,
- review of study protocols
- review of draft reports.
Where existing data is available, we can assist with data-sharing negotiations or development of cost compensation calculations.
CLP classification of substances and products
Regulation (EC) No 1272/2008, CLP, concerns the classification, labelling and packaging of chemical substances and mixtures which are released on the EU market. As of 1 June 2015, chemical products must be labelled in accordance with the requirements of the CLP Regulation.
The CLP Regulation requires manufacturers, importers or downstream users of substances or mixtures to classify, label and package their hazardous chemicals appropriately before placing them on the market.
One of the main aims of the regulation is to determine whether a substance or mixture displays properties that lead to a hazardous classification. In this context, classification is the starting point for hazard communication.
The information about the hazards and how to protect oneself and the environment is communicated to users through package labelling with e.g. hazard pictograms, signal words and hazard and precautionary statements. This and more information is also provided to professional users in the safety data sheets.
Be aware that provisions under Union legislation other than the CLP Regulation (downstream legislation) may be triggered by the classification of your substance or mixture.
Other requirements in the CLP Regulation deals with e.g.:
- Notification to the Classification and Labelling Inventory.
- The need to generate a unique formula identifier (UFI) and to submit mixture information to the appointed bodies in the Member State which is used for emergency health response (the Poison Centres).
- Harmonised classification and labelling
SDS development/review
Our staff develops safety data sheets (SDSs) designed to meet OSHA and GHS requirements while effectively protecting the health and safety of workers who use hazardous chemicals.
We’ll ensure that your SDSs are correctly prepared in the GHS 16-section format and using language that the target audience can understand. We can generate new SDSs for your products or convert existing MSDSs into fully compliant SDSs. Our services include:
- Authoring SDSs for new products
- Updating SDSs for existing products
- Generating SDSs to meet localized requirements for Canada, US and the European Union
- Ongoing monitoring of regulatory requirements and new health hazard data to ensure your SDSs are updated as new rules or data are available.
- Generating information needed for hazardous chemical product labels, such as pictograms, hazard statements and precautionary statements
Contact us now for more information