Chemical control in Europe
3.1 Notification of new substances
All new chemical substance which is not listed by other legislation must be characterized according to the notification scheme described in the 6th Amendment to the Dangerous Substances Directive (DSD) (79/831/EEC) to ensure that any risk for both human and the environment is assessed before the chemical is placed on the marked. Once assessed according to this notification scheme, a chemical substance is considered "new". For more information see: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31979L0831:EN:HTML
The European INventory of Existing commercial Chemical Substances (EINECS) is a list of nearly 100000 existing substances that have been put on the marked in the 10-year period to September 1981. Before EINECS compilation, there was no requirement for data of any kind to be provided. Subsequent notifications after this date in one or more member states are placed on the European LIst of Notified Chemical Substances (ELINCS).
In Europe, the 7th Amendment to the DSD includes the requirement for risk assessments on notified new substances to be conducted by a Competent Authority unless at least one of the following exceptions is contemplated:
- They already exist in commerce;
- They are polymers that do not contain more than 2% of a non-EINECS listed substance;
- They are substances covered by other separate legislation.
For a new chemical substance to be put on the market, the manufacturer/importer has to notify the Competent Authority of the Member State where the substance is first marketed. According to Annex V from Directive 67/548/EEC, the requirements of the notification process are linked to the volumes placed on the market.
Considering the review of the data requirements and in order to circulate the information and comments between the other Member States, a full notification has to be submitted 60 days before being put on the market. Once approved in one Member State, the chemical substance can be freely marketed in all the others Member States. However, as volume market increases, other trigger levels of notification require approval by the Competent Authority, as further testing requirements may be needed. The notification process system in the USA has to take place at least 90 days before manufacturing or importing.
3.2 Existing Substances Regulation
Before the adoption in 1993 of the Council Regulation on the evaluation control of the risks of the existing chemicals (EEC 793/93), there was no requirement for data to be provided for existing chemicals. This "Existing Substances Regulation" results from data provided to the European Commission by Companies manufacturing or importing more than 10 tons per annum of an existing substance. Data submission is provided in the electronic format "Hedset" (Harmonized Electronic Dataset), managed by IUCLID (International Uniform Chemical Database). Considering animal, human and environmental safety, this regulation emphasizes the need to provide all the chemical data available, but no additional testing information has necessarily to be performed to complete specific data set of "Hedset".
The information required in this regulation typically includes the chemical name, production/import quantities, classification and labelling, reasonable foreseeable uses, chemical fate and pathways, physicochemical properties and (eco)toxicological data. Providing this data ensures the answer to the four main objectives of the "Existing Substances Regulation": data gathering, priority setting, risk assessment and risk management.
The use of a priority setting scheme enables the European Commission to perform a State Member open access list of chemicals that require a full risk assessment. Each Member State then nominates a Competent Authority to perform the risk assessment of selected chemicals. Once completed and if no further work is required, risk management measures may be implemented in view of risk reduction.
3.3 REACH: a new system control
Concerns of failures in the existing legislation system control framework led to the compilation of a White Paper on the Strategy for a Future Chemicals Policy, by the European Commission, published in February 2001 (COM (2001) 88). Considering human and environment health, this document contains an outlined strategy of chemical safety and proposes significant changes in the way in which chemicals are controlled by the implementation of a new system, known as REACH: Registration, Evaluation and Authorization of Chemicals.
Registration: All chemicals that are manufactured or imported in volumes greater than 1 ton have to be registered by submitting the physicochemical properties and (eco)toxicological data as well as the intended use.
Evaluation: Member States may perform an evaluation of higher volume substances and also substances of concern of possible risks to human and environment. From this evaluation further action or information may be needed, as well as regulation improvements.
Authorization: Industry can only use substances of very high concern after authorization approval in cases of foreseen negligible risks resulting from its use or when socio-economic benefits outweigh any risk, or other valid reasons that will be considered in the authorization application.
For more detailed information see:
European Chemicals Agency: http://echa.europa.eu/regulations
Agency for Toxic Substances & Disease Registry: http://www.atsdr.cdc.gov/substances/index.asp
3.4 Biocidal Products Directive (98/8/EC)
The Biocidal Products Directive (BPD) covers disinfectants, preservatives, pest control and other biocidal products and relates to the requirements associated to the release and use of these products in the European Union. This directive was implemented in 14th May 2000 to standardize the national authorization of biocidal products in Europe and to ensure a higher protection level to humans, animals and the environment. Biocidal products that were already considered in other EU Directives, such as the Cosmetics Directives (76/768/EC) are not affected by BPD.
According to this directive, biocidal products are defined as "Active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to destroy, deter, render harmless, prevent the action of, or otherwise exert a controlling effect on any harmful organism by chemical or biological means."
Biocidal active substances have to be assessed by all the Member States who will decide if they are to be included in Annex I, which is a positive list of biocidal actives that have been approved for use at the Community level (some restrictions may be applied). Biocidal products that contain one or more active substance indicated on Annex 1 list have to be authorized in Member States. Once accepted in one Member State they shall be authorized in the others Member States, according to the principle of mutual recognition.
3.5 Cosmetic Directive (76/768/EEC)
Taking into account human safety, cosmetic products in European Union are controlled by the Council Directive 76/768/EEC and its amendments. Annexes to the Directive provide lists of permitted substances, as UV filters, preservatives, colouring agents, but also a forbidden substances list.
Cosmetic products may be defined as any substance or preparation intended to be put in contact with external parts of the human body (epidermis, hair, nails, lips, etc...) or in the oral cavity for cleaning, protecting, perfuming or personal care purpose.
The supervision of the full compliance with the Directive for cosmetic products is ensured by the manufacturer/importer, and there is no pre-marketing notification requirement for these products.
Significant changes were introduced in this Directive by the "Seventh Amendment" (Directive 2003/15/EC. The marketing and testing of ingredients that were being tested on animals began to be forbidden when validate alternatives exist. All animal testing should have been phased out by March 2009. Due to the difficult replacing process for studies of reproductive toxicity, toxicokinetics and repeat doses, the deadline was extended to March 2013. Testing finished cosmetic product has been banned from the date of implementation of this Directive (11 September 2004). Moreover, all ingredients or finished cosmetic products that were tested on animals after this deadline will have to be included as such on the product information label, as well as fragrance ingredients. Regulation of category 1 and 2 carcinogens, mutagens and substances that are toxic for reproduction (CMR) will be forbidden in cosmetic products. Category 3 CMRs can only be used in cosmetics after approval by the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP). For more detailed information see:
http://ec.europa.eu/health/scientific_committees/consumer_safety/sccnfp/index_en.htm
Additionally, data on adverse side-effects arising from cosmetic products use, composition details and other relevant information must be of public open access.
3.6 Preparations
A preparation is defined as a mixture of chemical substances. The classification criteria for preparations with environmental hazards were implemented in all member states on 30 July 2002 by the Dangerous Preparations Directive 1999/45/EEC, which replaced the original 88/378/EEC. As a result, some existing preparations were then classified as dangerous for the environment as a result of ecotoxicity test data falling within the new limits of classification. Similarly, preparations that are covered by other legislations are not classified by the directive 1999/45/EC, such as cosmetics, medicinal and veterinary drugs. However, this directive includes plant protection products and biocides in order to implement a uniform approach to classification and labelling of dangerous preparations.
According to this new directive, when sensitizers are present in a preparation at a concentration between 0.1% and 1%, the supplementary labelling is "Contains (name of sensitizing substance), may produce allergic reaction". For instance, preparations containing more than 1% of a skin sensitizer substance (R43, may cause skin sensitization), would also be classified as having the same hazard property.
Moreover, unless the total volume does not exceed 125 ml or if they were already classified with R20, R23, R26, R68/20, R39/23 or R39/26, preparations that contain one or more substances that have been assigned R67: "Vapours may cause drowsiness and dizziness" require supplementary labelling if the total concentration is equal to or higher than 15%.
