Since 2007, the European Chemicals Regulation for the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) has been in force in the EU. The regulation regulates the manufacture and marketing of chemicals. The regulation affects not only manufacturers but also downstream users – i.e. companies that do not manufacture these substances themselves but process them further. The first step was to register chemical substances at the ECHA (European Chemicals Agency). This took place in three phases, the last of which was completed in May 2018. Since then, only chemicals that have been registered may be produced or placed on the market.
The next step is the evaluation of the registered substances by ECHA and the member states. If a substance is identified as particularly alarming, it is included in the REACH candidate list. The candidate list was last updated in July 2018. For these so-called SVHC (substances of very high concern), a date is set from which they may only be used for approved areas. This authorization is limited in time so that these substances may no longer be used after the deadline and should be replaced by other, less worrying substances. Of very high concern are those substances which are:
- carcinogenic, mutagenic or toxic to reproduction or
- toxic and persistent in the environment and in organisms, or
- very long-lived in the environment and accumulate very strongly in organisms, or
- possessing similar properties of concern (e.g. hormonal action).
ECHA is currently considering recommending that the EU Commission include 18 substances on the candidate list in the authorisation list (Annex XIV to REACH). Comments can be submitted until 5 December 2018. If a substance is included in the authorisation list, it may only be placed on the market or used after a certain date if an authorisation for a certain use is granted. Companies that use, manufacture or import these substances may apply for authorisation.
Other substances, not only SVHC, may also be restricted if “the manufacture, placing on the market or use of a chemical substance poses an unacceptable risk to human health or the environment, which must be dealt with at the community level”. This applies, for example, to chemicals that can enter the EU via imported products.
Throughout the supply chain, information on the substances used must be passed on from the manufacturer/importer to the processor/intermediary (= downstream user) and on to the final seller. Only this way the safe use of the substances can be guaranteed and the right of consumers to have verifiable true information taken into account. For the automotive industry, the REACH regulation can be observed with the help of the IMDS. Here, all data on the substances used can be entered and passed on. Prohibited substances and substances on the SVHC candidate list can be identified immediately. The specially developed Chemistry Manager in IMDS helps to simplify the reporting.
The Chemistry Manager can also be used to comply with the Biocides Ordinance, which has been in force since 2013. Biocides are substances or mixtures of substances that destroy, deter and render harmless harmful organisms such as fungi, mosquitoes and bacteria, prevent their action or are intended to combat them in some other manner. These include, among others, pesticides, insecticides, anti-mildew agents, etc. Only active substances on the European Union list of approved active substances may be used in biocidal products. An application for active substance approval must be submitted directly to ECHA. Substances that cannot be approved have the following properties:
- carcinogenic or
- mutagen or
- toxic to reproduction or
- endocrine or
- persistent, bioaccumulative and toxic (PBT substances) or
- very persistent and very highly bioaccumulative (vPvB substances).
In exceptional cases, substances with the above properties may nevertheless be authorized for a limited period (seven years), as may substances with the following properties:
- inhalation allergens or
- significantly more toxic than most active substances for the same type of use, or
- meet two of the three PBT criteria or
- also give cause for concern in the case of restrictive risk mitigation measures, or
- contain a significant proportion of ineffective impurities.
These substances, which are approved for a limited period of time, are candidates for substitution. This means that “before products containing these active substances are approved, it must be checked whether the intended use cannot be covered by other products”.
In addition to the individual active substances, the Biocides Ordinance also regulates products, treated goods and in situ biocides. Thus, only biocidal products whose active substances have been previously approved are permitted. Treated goods are “substances, mixtures or products which have been treated with one or more biocidal products or to which one or more biocidal products have been intentionally added”. For treated goods, the distributor must provide a label containing the following:
- a declaration that the treated goods contain biocidal products;
- where appropriate, the biocidal property attributed to the treated product;
- the names of all active substances contained in the biocidal products;
- the names of all nanomaterials contained in the biocidal products, followed by “nano” in brackets;
- all relevant conditions of use, including precautions to be taken with regard to the biocidal products with which or contained in the treated goods.
So-called in situ biocides are locally produced biocides, such as ozone generated from air. This means that air itself is not considered a biocide, but the ozone it produces is when it is marketed.