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CHEMICALS

Risk Assessment

Services

Alchemy Compliance can perform both human health and environmental risk assessment. Risk assessment is required for the notification of new chemicals, the registration of biocidal products, and is also part of the Chemical Safety Report in REACH. It is also the basis of the safety assessment for cosmetic products.

Alchemy Compliance can assess occupational, consumer and environmental exposures using measured data, or default data from current guidance documents, and computer modelling (eg EASE, EUSES). 

Further information

Chemical risk assessment – Human Health

Risk assessment is the pillar of chemical regulation that is concerned with the protection of man and the environment. It involves the evaluation of the substance by comparing its hazardous properties with the exposures of specified populations (industrial, professional, and consumer, and also those exposed via the environment), to estimate the likelihood that adverse effects will occur. Therefore, an assessor can conclude that an extremely hazardous substance can be used safely (ie has an acceptable risk), provided that there are no significantly exposed populations. The chemical industry is generally opposed to regulatory actions based solely on hazardous properties, while some environmental organisation would prefer this approach.

Chemical risk assessment covers the life cycle of a substance from manufacture through use and emissions to disposal, accounting for its properties, stability and effects at each stage. The risk assessment is used in regulatory schemes to determine further information requirements or risk reduction measures.

The aims and methods of chemical risk assessment for new (supplied after September 1981) and existing (supplied before that date) chemicals are given in a guidance document [Technical guidance Document in Support of Commission Directive 93/67/EEC on Risk Assessment for New Notified Substance and Commission Regulation (EC) no. 1488/94 on Risk Assessment for Existing Substances]. The guidance has been updated to incorporate biocide assessment. The guidance comprises four volumes:

• Chemical risk assessment for human health

• Environmental risk assessment

• Use of (quantitative) structure-activity relationships and use categories

• Emission scenario documents

The regulators aim is to protect people and the environment from adverse effects of the chemical. The risk assessment for new chemicals is based on a realistic worst-case scenario, and provides the basis for further testing, if necessary, either immediately after the notification or once a higher tonnage threshold is reached. Legislation relating to both new and existing chemicals seeks to ensure that the information requirements are proportional to risk.

For human health effects, we assess the risk to humans by comparing the calculated or measured exposure data for a specific human population with toxicological data extrapolated from animals. For non-systemic effects, such as irritation, the risk is controlled using risk management measures, such as personal protective equipment, or ventilation. The most important toxicological parameter for systemic effects is the no-observed-adverse-effect level (NOAEL). For new chemicals with base-set data, the NOAEL is derived from the 28-day repeat-dose study. The risk assessment is more complicated for effects where there is no identified threshold concentration, particularly some carcinogens and sensitising substances.

If the exposure estimate is equal to or higher than the NOAEL, the substance will be of concern with regard to systemic toxicity in the population considered. The assessor may decide that additional information, either on exposure or on toxicity, is necessary to refine the chemical risk assessment. For new substances, refinement of the exposure assessment is recommended before further in vivo studies are conducted, due to animal welfare considerations.

Where the exposure estimate is less than the NOAEL, the assessor decides the outcome of the chemical risk assessment on the magnitude by which the NOAEL exceeds the estimated exposure (ie the margin of safety, MoS). The required MoS is dependent on the uncertainty arising from the following parameters:

• Intra- and interspecies variation

• The nature and severity of the effect

• Route of exposure

• Specific populations exposed (young or old in human populations)

The assessor usually requires a MoS at least in the hundreds.

Environmental Risk Assessment

The assessor uses a different procedure for environmental risk characterisation. The aim is to protect ecosystems (not individual animals), using test data on representative species. For new chemicals, the base-set ecotoxicity battery comprises testing for acute effects in fish, Daphnia, and algae. In this case, we calculate a predicted no-effect concentration (PNEC) by dividing the LC50 concentration (concentration of substance that causes death in 50% of the test species) in the most sensitive species by an assessment factor of 1000. If data from longer-term studies are available, we calculate the PNEC from the no-observed-effect concentration (NOEC) by dividing by an assessment factor of 100 (for one long-term study) or 10 (two or three long-term studies available).

We obtain the predicted environmental concentration (PEC) either by measurement, or by calculation using release data and fate and behaviour modelling. Finally we divide the PEC by the PNEC and if this ratio is less than one, there is considered to be no immediate concern. If greater than one, the assessor may ask for more detailed information on the release of the substance, or more ecotoxicological testing, in order to refine the risk assessment. If the ratio remains unfavourable after refinement, risk reduction measures, including restriction on marketing or use, may be imposed.

The chemical risk assessment for new chemical substances has four possible conclusions:

• No immediate concern

• Further information required at the next tonnage threshold

• Further information required immediately

• Risk reduction recommendations (in addition to risk reduction measures already in place)

Existing chemicals, three conclusions:

• There is need for further information and/or testing

• There is at present no need for further information, or no need for risk reduction measures beyond those that are already being applied

• There is a need for limiting the risks: risk reduction measures that are already being applied shall be taken into account

Recommendations for risk reduction might include:

• Modifications to classification, packaging, labelling, the safety data sheet, or the recommended precautions or emergency measures

• Measures for the protection of man and the environment, such as limits for worker exposure or environmental discharge

• Restrictions on marketing under the provisions of 76/769/EEC are used very occasionally

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