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Registrant/Consortium

Anyone who manufactures or imports a chemical in the EU at >1 tonne per year is obliged to Register that substance. Companies who need to Register several similar substances may decide to act together in a Consortium to spread the costs involved in preparing the materials for submission. PFA offers consortium management services , overseeing cross-company liaison and acting as a guardian of confidential business information.

Substance identification

PFA checks that the substance each company intends to register is sufficiently similar such that the Chemical Safety Assessment is not affected by minor differences in composition. On the basis of information provided by our clients, PFA produces a document called a Substance Identification Profile (SIP). This defines the substance to be registered, and is sent to all potential Registrants so they can check if their substance meets this definition.

SIEF formation

A SIEF is a Substance Information Exchange Forum. They are intended to allow sharing of data on the intrinsic properties of substances in order to avoid duplication of data. There is a particular legal obligation to share test data involving vertebrate animals, so that the need for further animal testing can be reduced. The work of the SIEF leads to a single joint submission for each substance, and the SIEF can be formed once the substance identification is agreed. In addition to potential registrants, downstream users (companies who use chemicals but don’t manufacture/import), and anyone holding data on a substance, can become part of a SIEF.

Data on properties

PFA gathers data on the physicochemical properties (e.g. boiling point, water solubility, flammability), environmental fate (e.g degradation, adsorption to soil, bioaccumulation), ecotoxicology (e.g. toxicity to fish, plants, birds) and toxicology (e.g. short- and long-term toxicity to mammals, irritation, sensitisation) of the substance. This can be data that held by one or more of the SIEF members, or data available in the public domain (i.e. in journals or various databases). This is reviewed by our experts to ensure that the result is reliable and that the study fully meets the requirements for that particular property.

Identification of data gaps

REACH requires submission of data for numerous different properties/endpoints. The level of information required depends on the tonnage in which the substance is manufactured/imported. PFA compares the information requirements for the substance with the information available. We then consider whether it is possible to waive the requirement (i.e. justify that is it not necessary or possible to do the study) or fill the data gap using alternative methods. These methods include:

  • (Q)SAR (Quantitative Structure Activity Relationships) - predicting a result using various statistical models)
  • grouping of substances or read-across - taking data from one or more substances and using it to fill a data gap for a similar substance.

New studies (Toxicology, ecotox, physical chemical properties)

If any data gap cannot be filled using alternative methods, new studies will need to be commissioned. PFA will assist in liaising with testing laboratories and monitoring studies. Studies using animals are only done as a last resort, and may require the submission of a testing proposal to ECHA (European CHemicals Agency) to ensure that the study is really needed. A core aim of PFA’s work is the expert application of predictive methods in order to prevent unnecessary studies.

Hazard assessment (DNEL, PNEC)

  • DNEL – Derived No Effect Level (for human health)
  • PNEC – Predicted No Effect Concentration (for the environment)
  • Hazard communication needs (CLP)
  • Persistence, Bioaccumulation and Toxicity assessment (PBT)

Substances which are persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB), present particular environmental concerns, and assessment of these properties of a substance is a key aspect of hazard assessment.

DNEL and PNEC are notional safe levels. At this level the chemical is not considered to present an unacceptable risk to the environment or human health (i.e. the substance is very unlikely to do any significant harm). These are calculated using results from toxicological studies or relevant predictive methods, accounting for factors such as variability in experimental results, differences between species, and other uncertainties.

Classification and Labelling

The properties of the substance are compared to criteria set out in the Classification Labelling and Packaging of Substances and Mixtures Regulation (CLP) for physical, environmental , and human health hazards. If a substance meets the criteria for classification there are obligations to label the substance in such a way that the hazard is communicated.

Data on life cycle and use pattern

REACH requires information on all of the uses of a substance, accounting for its whole life-cycle, from manufacture to disposal, in order to asses all the possible routes of exposure to humans and the environment that may result from any of these stages. This data collection involves communication with downstream users to find out what they are doing with the substance, which PFA can assist with.

Exposure modelling

This involves predicting the levels of the chemical to which humans (people working with chemicals as well as the general population) and the environment are likely to be exposed.

Environmental exposure modelling involves estimating how much of the substance used is released into the environment, and what happens to it when it gets there, i.e. is it dissolved in water, is it adsorbed to soil or sediment?

In modelling exposure to humans, factors considered include the processes involved in using the chemical, the duration of exposure, the level of ventilation, and whether any personal protective equipment (gloves, breathing apparatus) are used. Separate assessments for workers at industrial sites, professional users, and consumers are carried out. Initial (tier 1) models are fairly simple and give conservative estimates.

Further data

If the simple tier 1 estimates of exposure are not adequate, because when compared to the notional safe level they suggest that the chemical may present a risk, then the modelling can be refined or measurements of exposure can be made.

Exposure assessment

Exposure modelling leads to estimates of the concentration of the chemical in each environmental compartment (water, sediment, soil, air) and estimates of the levels of the chemical to which humans are exposed via oral, dermal and inhalation routes.

Risk Characterisation

Risk Characterisation involves the comparison of the predicted exposure levels with the notional safe levels (PNEC/DNEL) for each use. If the exposure level is higher than the safe level then the models have to be refined or further risk management measures have to be put in place to limit exposure to the chemical. If a particular use of a chemical is still unsafe after all refinement and reasonable risk management measures have taken into account, then the Registrants will need to consider not supporting that particular use in their Registration dossier.

Registration dossier (IUCLID, CSR)

  • IUCLID = International Uniform Chemical Information Database. Summaries of substance identity, classification and labelling, use pattern, and property are entered into this database. It is free software which is a key tool in meeting data submission requirements for REACH. PFA is able to document all parts of the technical dossier which are not specific to the registrant, using this software.
  • CSR = Chemical Safety Report. This report documents the whole process discussed above of hazard assessment, exposure assessment and risk characterisation.

Revisions

At each stage of the process, PFA keeps in close contact with the client. They have the opportunity to review documents at various stages of the process if desired. This is particularly important when the CSR and IUCLID are drafted. The client reviews the documents and then PFA acts on the comments.

Registration by LR

LR is Lead Registrant. Each SIEF nominates a Lead Registrant. The LR has a vital role to submit a complete and compliant registration in a timely manner. Other registrants within the SIEF may then submit only company-specific information in their own registrations.