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 products
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.
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
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 has 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 chemical 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 is 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.
Contact us now for more information