What are product safety and consumer risks?
It is self-evident that products should neither harm their users nor the environment, but what is not always so obvious is what this actually means in practice.
Businesses must ensure that their products are safe for consumers to use, i.e. if mixtures are used for the purposes for which they are intended, no risks should arise. At the same time, it is also important to focus on environmental safety, and to take a holistic view of the impacts of your products.
What are the advantages of ensuring product safety?
Assessing legal compliance thoroughly and including further considerations about product safety in evaluation procedures can help to:
- Prevent liability claims and potential damage to the brand name, as potential risks are identified and can be managed
- Foster better understanding not only of the benefits of the own product but also its potential drawbacks and hence, identifying improvement potentials
- Support the development of green claims and/or the application for ecolabels, as well as to identify aspects that could also be used for marketing purposes.
What are the legal requirements?
REACH Annex XVII restricts the use of certain substances in mixtures made available to the general public, where those substances exceed specified concentration limits. In particular, these restrictions apply to substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMRs) of categories 1A or 1B. Annex XVII also contains substance-specific restrictions, and additional restrictions may be introduced in the future.
The EU General Product Safety Directive, which is transposed into national legislation, stipulates that products on the market should not cause any harm to consumers under normal and foreseeable conditions of use. The scope of this Directive includes all products intended for consumer use or which may reasonably be assumed to be used by a consumer. Hence, all mixtures which are freely available on the market, including in DIY stores, are covered by this legislation.
Although the legislation does not prescribe or provide any specific methodology for the risk assessment; compliance with product-specific standards is regarded as one means of ensuring safety.At the same time, there are additional requirements for specific mixtures available to consumers, such as detergents or cosmetics, which are briefly introduced in the Overview of Legislation.
How should product safety be assessed?
Compliance check
- Does the mixture contain any restricted substances over permitted concentration limits?
- Is the classification of the mixture correct?
- Does the product label comply with all requirements?
- Have the authorities been notified about the mixture (cf. section 12.3.4)
- Does the product conform to existing standards, e.g. under the construction products regulation?
Consumer risk assessment
To perform a qualitative assessment, consider the mixture’s classification, how it is normally used, and which exposures could occur. You may have to investigate this in more depth in the event that the hazards posed by substances and their exposure routes indicate potential risks at a qualitative level.
In the qualitative assessment, anticipate the normal use of the mixture and identify all potential consumer exposures. Check if dermal contact is possible and which areas of the skin may be exposed and for how long. Consider if spills could come into contact with the eye. Assess whether substances in the mixture can be inhaled via aerosols, vapours or as dusts. Check ingestion possibilities, e.g. dishwashing agents remaining on dishes.
To identify a risk, compare the exposure levels with the effect thresholds quantitatively. If the mixture contains a considerably hazardous substance and the user is most likely significantly exposed, in all probability you may immediately conclude that the risk is unacceptable and seek a substitute mixture.
Risk reduction measures for products
Substitution is the most far-reaching and effective risk reduction measure provided that alternatives are available that are less harmful. Hence, if there are concerns that a mixture could cause consumer risks, this should be the first measure to evaluate.
One example is washing agents for textiles: instead of providing them in the form of powders, alternatives with lower exposure potential are liquids (no dusting, but risk of spills to the skin) or pre-packaged washing powder portions contained in packaging that dissolves in the washing machine (no dusting, no direct contact with the skin).
Similar approaches exist in the transition from spray to foam applications or to design packaging whereby dosing or pouring is less prone to lead to skin exposure.
Step-by-step
Assign Product Safety Assessment Responsibilities
Identify staff who could implement a product safety assessment in terms of competences and resources; if competences are lacking. Identify options for training personnel to perform at least a qualitative risk assessment of products.
Prioritise Mixtures for Risk Assessment
Prioritise mixtures for risk assessment based on their classification and/or content of hazardous substances.
Define the Scope of the Product Safety Assessment
Define how comprehensive the product safety assessment should be: as a (legal) minimum, it must be assessed that the mixture does not cause any harm to the user in the course of normal and foreseeable use. Extensions of this scope could:
- include environmental safety;
- assess product safety along the entire lifecycle, e.g. up and down the supply chain and regarding waste treatment;
- assess the sustainability of a mixture, i.e. including non-toxic environmental impacts such as on climate change or resource use.
Carry Out and Document the Mixture Assessment
Carry out and document the assessment of one or more mixtures and identify if preventive actions are required. The assessment may start with a screening/qualitative approach and be refined if the results are ambiguous or are deemed to be as too rough for credible
Interpret Results and Implement Follow-Up Actions
Interpret the results:
- if no action is needed, record the assessment and proceed to the next mixture;
- if action is required: inform the relevant staff of the assessment results and identify options to reduce risks. Monitor implementation and assess results.
Tools and Links
- Expert tools for the assessment of consumer risks from mixtures:
- ConsExpo
- ECECTOC TRA consumer tool (Download necessary)
- Database on restrictions under REACH (Annex XVII)