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.
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 CRO,
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.
Safety Data Sheet development
EU and Northern Ireland
The safety data sheet (SDS) provides a mechanism for communicating health and safety information about hazardous substances and mixtures. Requirements are given via standalone legislation that can be thought of as the current version of Regulation (EC) No 1907/2006 Annex II. It is also important to know that an SDS is always needed for a biocidal product, regardless of whether it is classified. The document must be available during the process of poison centre notification and for product authorisation under the Biocidal Products Regulation (BPR).
The format and content of an SDS is defined by law. The document must follow an internationally agreed 16-section structure and incorporate headings/sub-headings that are specific to the EU. Unless local legislation states otherwise, the SDS must also be supplied in an official language of the EU Member State(s) where the substance or mixture is placed on the market.
New EU safety data sheets must be written in accordance with the more complex rules given by Regulation (EU) 2020/878 after 1st January 2021. Additional information requirements include substances placed on the market as nanoforms and substances/mixtures with endocrine disrupting properties. It is also now mandatory to include Specific Concentration Limits (SCLs), multiplying factors and any acute toxicity estimate (ATE) if these have been set in accordance with Regulation (EC) No 1272/2008 (CLP).
Distribution of existing EU safety data sheets that conform to the previous EU legislation –Regulation (EU) 2015/830 – may continue between 1st January 2021 and 31st December 2022 in the following scenarios:
• No change to EU-format safety data sheet.
• Small amendment to EU-format safety data sheet that is not driven by new hazards, changes to risk management measures, authorisation or restriction as specified in EU REACH Article 31(9).
• Necessary update to EU-format safety data sheet such as introduction of the Unique Formula Identifier (UFI).
To ensure compliance of all safety data sheets intended for circulation in the EU by the deadline of 31st December 2022, it is recommended that existing documents are converted to the new format as soon as practicable.
England, Scotland and Wales (GB)
The format and content of GB safety data sheets will increasingly diverge after 1st January 2021 because Regulation (EU) 2020/878 was not adopted at the end of the Brexit transition period. In particular, it should be noted that substance/mixture classification may be different and that a Unique Formula Identifier (UFI) is not required for mixtures. Arrow Regulatory will be pleased to provide further information as the new systems mature.
Safety Data Sheet review
Suppliers are required to routinely review, revise, and update each safety data sheet (SDS). Amendments often become necessary when product information is modified by re-formulation, identified uses are added or removed, additional hazard information is found, or protective measures change.
The document is intended to be of practical use to the recipient and, for this reason, it is set out in a standard format where information should be easily located. However, it is a complex task to ensure that safety data sheets are correct and consistent throughout the 16 sections.
Arrow Regulatory have significant experience of reviewing safety datasheets and can offer detailed advice on request. Subjects that will be considered during the review include:
Administrative information such as supplier details.
CLP classification to ensure it is correct and consistent with the label elements shown on the safety data sheet plus the physical product label.
Information on ingredients to check declarable substances are not omitted and concentrations (including any concentration ranges) align with the overall CLP classification.
Description of first aid measures to verify particulars are appropriate to the product and achievable at the point of end use.
Stipulated firefighting measures to ensure they are suitable for the product but do not attempt to impose conditions that professional firefighters may consider inappropriate.
Details of how to clean up large and small spills by professional services or the end user and whether the size of spill is defined.
Expected conditions of use to confirm these are consistent with instructions given for handling and storage.
Description of exposure controls and personal protection.
Stability and reactivity to check that decomposition and potential hazards in situations other than during a fire are described.
Physico-chemical properties, toxicological data and ecotoxicological data with reference to information disseminated by the appropriate regulator.
Disposal considerations with a view to making instructions product specific rather than simply ‘in accordance with national regulations’.
Transport information to confirm it is correct.
Regulatory information with the aim of making details appropriate to the product and the country where it will be placed on the market.
Inclusion of abbreviations and full text of hazard and precautionary statements plus a list of sources to assist the recipient with checking the SDS quality
IUCLID (International Uniform ChemicaL Information Database) is used to manage scientific data on chemicals in a regulatory context and is mandatory within the framework of REACH and BPR. The use of the format has also been extended to encompass poison centre notification (PCN) and for plant protection product applications.
The IUCLID software was built as a platform meant to provide regulatory authorities and industry with a set of tools to manage information on chemicals, using a common format, facilitating the reuse and exchange of the data. It is required for the recording, storage, submission, and exchange of data on chemical substances or mixtures in the format of the OECD Harmonised Templates.
The OECD Harmonised Templates 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. The templates prescribe the formats by which information can be entered into and maintained in a database.
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.
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.