Risk Assessment

The assessment of risk to human health and the assessment of risk to the environment are important parts of the documentation in the registration of chemicals, authorisation of active substances and biocides, and manufacture of cosmetic products.

Irrespective of the area for which you need risk assessment, our experience allows us to reach your goal.

The principle of the above described risk assessment is uniform irrespective of legislation; nevertheless, the methodology (prescribed scenarios, modelling tools …) is specific to the type of chemical under assessment.

In the authorisation of active substances and biocidal products, risk assessment constitutes an integral part of the documentation that needs to be submitted to the competent authorities. It must be demonstrated that the substance or product is safe for use, taking into consideration the specified intended use.

The methodology to assess the risk and exposure and to specify the risk for biocidal active substances and products to human health is described in the Guidance on the BPR: Volume III Human Health, Assessment + Evaluation (Parts B+C).

The methodology to assess the risk and exposure and to specify the risk to the environment is described in the Guidance on the BPR: Volume IV Environment, Assessment & Evaluation (Parts B+C).

Risk assessment for substances is an integral part of the documentation to be submitted to ECHA for:

• Substance registration procedure (for substances sold in quantities > 10 t/year);
• Substance authorisation procedure, and
• as part of the obligation of a downstream user if they did not receive a suitable exposure scenario

Guidelines to prepare risk assessment for substances are published on the ECHA websites – Guidance on Information Requirements and Chemical Safety Assessment

Before marketing cosmetic products, risk assessment for human health must be done in accordance with the Guidelines of the Scientific Committee on Consumer Safety for testing cosmetic substances and their risk assessment.

The assessment is based on safety assessment for each substance separately. The intended purpose of the cosmetic product and the expected systemic exposure to each ingredient of the finished product must be taken into account.

It is important to update the cosmetic product safety report also after placing it on the market.