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.
Biocides – Registration / Authorisation
Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensationRegulatory strategy developmentProject management and study monitoringCLP classification of substances and productsPreparation of IUCLID dossiersOECD Harmonised TemplatesRisk assessmentPoison Centre NotificationsSelling chemical products onlineRegulatory submissions
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.
For example complex services for registration under transitional period or authorisation once the active substance is approved:
- Documents preparation including relevant forms and processes
- Efficacy assessment
- R4BP / IUCLID / SPC
- Biocidal product entry in the Register of EU MS or EU wide
- Material Safety Data Sheet (MSDS)
- Text part of the label
- Instructions for use, if not stated on the label
Application types Article 95: List of active substances and suppliersTechnical equivalenceIn situ generated active substancesTreated articlesRegistration/notification of biocidal products under transitional provisions
Understanding Biocidal Products Regulation
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) provides a regulatory framework for biocidal products placed on the European Union market. The BPR entered in force in September 2013 and replaced the Biocidal Products Directive (Directive 98/8/EC).
The biocidal product requires an authorisation at national or EU level before it can be made available on the market or used.
Access to the market is based on a two-step procedure:
- The active substance to be used in a biocidal product or to treat an article must be approved (assessed positively for its efficacy and safety in the relevant product type).
- After the active substance has been authorised as per step 1, biocidal products that contain the active substance can be authorised in an approval procedure.
If the active substance is not yet approved but is in the Review Programme, the biocidal product can be made available and used in accordance with national laws (transitional provisions).
Our services:
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Data gap analysis, data evaluation (reliability and acceptance), data-sharing and compensation
Ekotoxikologické centrum Bratislava, s.r.o. has experienced specialists in toxicology, environmental fate, aquatic and terrestrial ecotoxicology and higher-tier exposure modelling. We are skilled at applying this knowledge and experience at the EU and Member State levels in support of our clients’ product registrations, as well as outside the EU.
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:
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- 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.
- Endpoint completion strategies; test programmes for phys-chem, analytical, toxicity, ecotoxicity, environmental fate, efficacy for biocides or alternative waiving arguments.
- Data Gap Analysis
·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;
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- obtaining quotations and assistance on choosing a testing facility,
- review of study protocols
- review of draft reports.·
- review of study protocols
- obtaining quotations and assistance on choosing a testing facility,
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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 reqirements 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
Preparation of IUCLID dossiers
IUCLID plays a central role in the IT environments of all organisations that manage scientific data on chemicals in a regulatory context, for example under the OECD HPV, EU Biocides, and EU REACH:
- Industry stakeholders
- EU Member States
- The European Chemicals Agency (ECHA)
IUCLID is the essential tool for any organisation or individual that needs to record, store, submit, and exchange data on chemical substances in the format of the OECD Harmonised Templates.
OECD Harmonised Templates
The OECD Harmonised Templates (OHTs) are standard data formats for reporting information used for the risk assessment of chemicals, mainly studies done on chemicals to determine their properties or effects on human health and the environment, but also for storing data on use and exposure. They are aimed at developers of database systems, as they prescribe the formats by which information can be entered into and maintained in a database. ·By using these templates, governments and industry are easily able to electronically exchange test study summary information. The templates can be used to report summary test results for any type of chemical (e.g., pesticides, biocides, industrial chemicals, food/feed additives).
Risk assessment
Risk assessment is the process used to determine if a substance/product is safe for a prescribed use. The process follows three basic steps:
- Hazard characterisation; determination of the relationship between dose levels and response, where the dose relates to the level of substance/product involved and response to the adverse effect observed.
- Determination of the level of exposure; the extent to which the object of the assessment is exposed to either the substance/product.·
- Risk Characterisation: data from the hazard characterization is compared with the exposure assessment to determine the risk nature and magnitude, and necessary risk management protocols.
Poison Centre Notifications
According to Annex VIII to the CLP regulation (EC 1272/2008), importers and downstream users placing hazardous mixtures on the EU market must notify their products to the nationally appointed bodies. This EU Poison Centre Notification is a legal obligation neither covered by existing REACH or CLP notifications. The notification has to be submitted in each Member State where the mixture is intended to be made available on the market. Annex VIII establishes compliance deadlines for Poison Centre Notifications depending on the type of their use:
- Consumer and professional use (since 1 Jan. 2021)
- Industrial use (by 1 Jan. 2024)
To allow the appointed national poison centres to unequivocally identify the concerned mixture(s) in case of a reported emergency, a harmonized format for notifications have been created, along with a Unique Formula Identifier (UFI) which needs to be placed on the product label.
Related services
- Preparation of active substance approvals and biocidal product authorisations (BPR and Transitional Arrangements)
- Development of Biocidal Product Families
- Development of Authorisation strategies
- Planning of test programmes, including efficacy testing
- Technical Equivalence Applications
- Obtaining Article 95 status
- Renewals of active substance approvals and biocidal product authorisations, including Comparative Assessment
- Product Label Reviews
We review labels for regulatory compliance – and correct language, verifying the inclusion on the label of any proper any hazard information for a given substance or mixture to the user. This enables the user to best protect himself during use. The responsibility for labelling lies with the manufacturer of a substance, an importer of a substance or a mixture and/or downstream user i.e. a formulator of a mixture who supplies, or makes available,· hazardous substances and/or mixtures to a third party, whether professional or consumer, within the European Union (EU). Where a hazardous substance or mixture is being sold online, there is also a requirement to communicate the hazard(s) of that substance or mixture in the advertisement.
Selling chemical products online
If selling hazardous chemicals products on a company website or on a marketplace platform (e.g. eBay) it is essential that the advert for those products complies with the requirements of the REACH and CLP Regulations. Such chemical products include glues, sealants, cement, paint, arts & crafts, car care products, cleaning products, scented candles or jewellery.
- Under Article 48 of the CLP Regulation, the advertisement for any hazardous chemical product must include relevant hazard information. For example, if a product is classified as irritating or sensitising to skin, then the advert should either include a copy of the hazard label (hazard pictograms/hazard statements) or include the hazard information in the product description. This allows the consumer see and understand what the potential hazards of the products are before they buy it online.
- The easiest way to comply with this legal requirement is for sellers to include an image of the product container/packaging (front and back) with a zoom function. If that is not possible, the information from the hazard label or from Section 2.2 of the safety data sheet (SDS) for that same product should be copied and pasted into the online product description. The requirement to include hazard information in online adverts only applies when a purchase can be concluded online so does not apply when a website/platform only offers a reserve/collect-in-store option, as the sale is not concluded online.
- Under Article 31 of the REACH Regulation, there is a requirement to provide a safety data sheet (SDS) when selling chemical products to industrial and professional users, e.g. builders, cleaners, mechanics. This obligation extends to online sales also. To meet this obligation there a number of options available. The SDS can be added to the online advertisement of the product either as an attachment (PDF) or as a direct link (URL) on the website. Alternatively, a hardcopy of the SDS can be provided in the delivery box of the product ( for professional/industrial users only ) and/or emailed to them as an attachment (PDF) or direct link (URL) on or before its first supply date, and thereafter if the SDS is updated within 12 months .
- Under Article 67 of the REACH Regulation, certain very hazardous substances are restricted either entirely (banned) or partially, meaning that certain conditions apply to their use or placing on the market, to ensure safe use for general consumers and workers, for example, nickel in jewellery, isocyanate in foam fillers, lead in solder wire or cancer causing chemicals used in consumer products. Compliance with these restrictions is the same regardless whether being sold online or in a retail store, therefore, all chemical products being sold online must be compliant.
- Advice on treated article status and labelling
- Regulatory submissions and post-approval support and asset management
- Regulatory submissions
- Once your application has been prepared we can also help you with submission of the application through the relevant authority gateways, e.g. R4BP3, REACH-IT and with any post-application support;
- Discussions with the regulatory authority
- Participation in peer-review processes, such as ECHA Working Groups meetings.
Where existing data is available, we can assist with data-sharing negotiations or development of cost compensation calculations.
Companies wishing to place biocidal products on the market can apply for product authorisation at National or Union level under the following application types:
Registration of biocidal products under transitional provisions in Slovakia
Contact us now for more information
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