Are there safer alternatives?
Safer chemicals are good for consumers and good for business. Companies using them can enhance their brand, bringing economic benefits.
The term "substitution" means replacing a hazardous substance with one which poses less or no risk; changing the production process; or switching technology. Different risk management measures promote substitution.
Under REACH, companies need to register chemicals manufactured or placed on the EU market at quantities above one ton per year. When collecting data and classifying their substance to submit the registration dossier, companies need to identify if certain uses of their substances are no longer desirable because they cannot be managed safely. In such cases, companies can either stop manufacturing or importing the substance or advise against using it for the problematic uses. The registration obligations include incentives for chemical manufacturers or importers to move away from non-desirable uses of substances and to find safer alternatives.
Classifying chemicals means defining their hazards to ensure that they are manufactured, used and disposed of safely. More than 20 EU laws refer to the classifying and labelling of chemicals, meaning that once a substance is classified as hazardous, other legal requirements kick-in to control their use. If substances cannot be placed on the market for certain uses because of their classification, companies need to find alternatives.
For example, substances which are classified as carcinogenic, mutagenic or toxic for reproduction cannot be used in consumer products or in mixtures above certain concentration levels. Only a few exemptions exist.
For consumers, it is important to read and understand the labels on products or mixtures. Based on this information, you can use them safely or choose less hazardous alternatives.
Restrictions may limit the manufacture, import, placing on the market or specific uses of a substance. If the restriction takes the form of a ban on all or specific uses of a substance, safer alternatives have to be found. With restrictions, unacceptable risks to human health and the environment can be avoided.
- The use of mercury has been banned in fever thermometers and other measuring devices for consumers, such as manometers or barometers. Most fever thermometers are now electric. In this case, the substitution resulted in changes in technology.
- A maximum concentration of chromium VI in leather articles is set in a restriction. Tanneries in the EU have developed alternative methods to tan hide. This happens either by improving the production process (still based on chromium compounds, but avoiding the generation of chromium VI) or by using chromium-free techniques.
The Candidate List includes substances of very high concern that are particularly harmful for human health or the environment. This is a strong incentive for companies to intensify their efforts to find alternatives for these substances.
If a substance of very high concern is included the Authorisation List, the use or placing on the EU market after a specific date is forbidden unless authorisation has been requested and granted. To apply for an authorisation, companies need to perform a detailed analysis of alternatives for the uses of their substance. They have to demonstrate that the risks of using the substance are small. In certain cases, they also need to show that the benefits for society are higher than the risks posed and that there are no suitable alternatives available.
If uses of substances in the Authorisation List can easily be substituted, they are likely to be abandoned. The uses without suitable alternatives may remain until an alternative is found – as long as these uses have been authorised.
- ECHA did not receive any applications from industry for authorisation to use Musk xylene, a fragrance which is very persistent and very bio-accumulative; or MDA (4,4'- Diaminodiphenylmethane), which is carcinogenic. Thus, only substitutes to these substances can be used afterAugust 2014.
- The volume of DEHP (Bis(2-ethylhexyl)) - a phthalate widely used in soft PVC articles - manufactured or imported in Europe has decreased in recent years and industry has developed safer alternatives. The use of phthalate needs to get an authorisation.
- The flame retardant HBCDD (mainly used in polystyrene insulation materials) has been identified as a persistent, bio-accumulative and toxic substance several years ago. Industry has found alternatives to this substance. If some companies cannot use these alternatives, they will apply for an authorisation.
These examples show that substitution has already happened or is on its way.
For the approval of biocidal active substances, there are certain exclusion criteria concerning, for example, carcinogenicity, reproductive toxicity and toxicity in the environment. If any of those criteria is fulfilled, either the substance cannot be approved or its use has to be restricted.
If an active substance is approved for use although it fulfils one or more of the exclusion criteria, it is considered as a candidate for substitution. A substance can also be a candidate for substitution if it meets certain other criteria specified in the Biocidal Products Regulation.
Where these criteria are fulfilled, ECHA launches a public consultation to find alternatives to the substance. During this consultation, third parties can submit information on available safer alternatives, like other biocidal active substances or non-chemical alternatives.
In addition, biocidal products containing an active substance that is a candidate for substitution, will undergo a comparative assessment before authorisation. The assessment is done to find out whether there are safer alternatives on the market. If safer alternatives are available and they are effective, the use of the biocidal product can be prohibited or restricted.