A few words
IMDS
Role In Regulatory Complaince
REACH What it is.
It is a regulation that provides for mandatory Registration, Evaluation, Authorization and restrictions on the production, marketing and use of CHemicals. Chemicals manufactured or imported in quantities above 1 ton / year will be subject to registration in the central database. Some groups of substances will not be subject to the above-mentioned obligations (like some intermediates, polymers and some chemicals subject to other EU legal acts). The amount of information required will depend on the tonnage level and the risk that the substance poses to health or the environment. The database will be managed by the European Chemicals Agency based in Helsinki (Finland).
The production or use of substances assessed as having a negative impact on health or the environment will require authorizations issued by the European Commission for placing on the market in selected directions of use. Permission to use the substance (e.g. for production and marketing) will be granted if the risks arising from its use are properly controlled.
The REACH regulation imposes new obligations primarily on companies producing in the EU or importing into the EU chemical substances on their own, in preparations (in the case of imports) and in products (in the latter case in certain specific situations – e.g. toys, office supplies, e.t.c.). The new obligations also apply to all enterprises using chemical products (e.g. wood, metallurgy, paper, glass, cosmetics, lime, cement, metal and plastic processing industries).
The REACH regulation entered into force on June 1, 2007.
More information at
Registration After the entry into force of the Regulation, any substance placed on the market in the Community in quantities of 1 tonne or more will have to be registered by the manufacturer or importer in the European Chemicals Agency. The registration deadline and types of registration documentation required will depend on the annual turnover. Refusal or non-registration will mean that this substance cannot be present on the Community market.
The registration obligation will apply to the substance placed on the market on its own and as an ingredient in the preparation, and in some cases also as an article ingredient (if the substance is classified as hazardous and intended substances from the article are intended under normal use). The preparations themselves are not subject to registration.
An efficient registration process for ‘phase-in’ substances is to ensure the timetable according to which registration of phase-in substances is spread over 11 years from the date of entry into force of the REACH Regulation.
First (within 3.5 years from the date of entry into force of the Regulation, i.e. by the end of November 2010), substances with an annual turnover exceeding 1000 tonnes and substances classified as carcinogenic, mutagenic or toxic for reproduction will be registered .
Subsequent registration deadlines (depending on the volume of annual turnover) calculated from the entry into force of the Regulation will expire:
for substances with an annual turnover of 100 – 1000 tonnes – 30 November 2013.
for substances with an annual turnover of 1 – 100 tonnes – May 31, 2018.
‘New’ substances notified in accordance with current legislation will be considered as registered. Phase-in substances will be subject to pre-registration from June 1, 2007. until November 30, 2008
Pre-registration is a prerequisite for using the transition periods for phase-in substances.
Chemical risk in all European Union countries will be a standardized harmonization of the obligation to analyze the impact of chemicals on human health, including employees.
The manufacturer or importer registering a substance will be required to assess the risks arising from its use and demonstrate that these risks can be controlled and managed in an appropriate manner. The manufacturer or importer will be responsible for gathering the information necessary to carry out the chemical risk assessment for the substances manufactured or imported. In many cases, it will be necessary to carry out appropriate tests for substances (e.g. ecotoxicological and toxicological).
The registrant of the substance in the Agency (manufacturer or importer) will be required to have a technical documentation (dossier) containing, among others manufacturer identification data, substance identification data, information on the manufacture and use of the substance, classification and labeling, and directions for the safe use of the substance.
The scope of information to be submitted for the purposes of substance registration and assessment depends on the turnover, the use of the substance and the exposure it presents. Detailed requirements in this respect are set out in Annexes VI-XI to the REACH Regulation.
For substances with an annual turnover of at least 10 tonnes, the manufacturer or importer will have to draw up a chemical safety report (RBChem). This report should contain a classification of hazards posed by a substance and an assessment of whether, according to the criteria specified in the Regulation, it is persistent, bioaccumulating and toxic (so-called PBT substances) or is very persistent and very bioaccumulating (so-called substances vPvB).
If the substance is classified as hazardous, the PBT or vPvB chemical safety report must include exposure scenarios for the identified uses of the substance with recommendations for exposure monitoring and risk reduction measures. The scenarios must cover all the anticipated uses of the substance. Exposure scenarios will be attachments to safety data sheets provided to downstream users and distributors of substances.
Chemicals produced or imported in quantities below 10 tonnes / year will not require the provision of chemical safety data. Manufacturers will only have to ensure that they have ‘adequate control’ over them.
REACH imposes on participants so-called the supply chain, an obligation to provide information on the hazardous properties of the substance, 4 health or environmental hazards and the risk reduction measures applied.
The communication of this information will take place both down and up the supply chain. The most important document will be the safety data sheet, if necessary expanded or supplemented with relevant attachments.
Chemical risk assessment will be an important element used in assessing the occupational risk occurring at their workplace so important for those working in contact with chemicals.
Expectations in relation to REACH
The REACH system will allow employers, through a chemical risk assessment carried out on the basis of common principles in all EU countries, to obtain reliable information on the chemicals used, produced and utilized. As a result, the information provided to employees about the occupational risk occurring at individual workplaces will be more accurate and reliable. In addition, at each stage of the route of chemicals it will be necessary to analyze the need for their use and the correctness of occupational exposure mitigation measures taken.
The effect of entry into force of the REACH regulation will also be the reduction of environmental protection costs due to the introduction of substances with less and less negative impact on the natural environment.
The REACH regulation will impose a number of new obligations on the chemical industry. It will also require supervisors and controls to have a professional approach and consistency in enforcing its provisions. Supervisory and control authorities will be able to check the effectiveness of implementing the regulations contained in this Regulation, verify their correctness and, together with employers, through issued recommendations, strive to fully implement the new European regulations in the field of chemicals and increase the safety of employees.
REACH should therefore significantly support the effectiveness of the current law on the protection of employees against exposure to hazardous chemicals in various industries and should help combat the risk of occupational diseases by:
providing necessary information on the chemical properties of substances and how to reduce the risk during their use;
implementing communication along the user chain;
encouraging substitution of less hazardous substances through authorization and registration procedures.
The Regulation does not apply to:
waste (they are not a substance, preparation or article within the meaning of Article 3 of the Regulation),
- radioactive substances,
- substances subject to customs control,
- non-isolated intermediates,
- transport of dangerous goods,
- substances in medicinal products, in food or in animal feeds
ELV Annex II
Article 4(2)(a) of the ELV Directive 2000/53/EC prohibits the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003, whereas the revised Annex II lists vehicle materials and components exempt from the prohibition set out in Article 4(2)(a) thereof.
For materials and components in Article 2(c), 3 and 5, the use of lead is unavoidable and its substitutes may become available in the near future, thus a new review date for that exemption should be set, taking into account the progress in the development of substitutes. Consequently, the European Commission has issued the amendment to replace the Annex II to Directive 2000/53/EC. The specific terms refer to the relevant link at the end of the text.
Directive (EU) 2017/2096, to amend Annex II to Directive 2000/53/EC on end-of life vehicles, which is related to exemption requirements of materials and components of vehicles.
Biocidal Products regulations
The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) concerns the placing on the market and use of biocidal products, which are used to protect humans, animals, materials or articles against harmful organisms like pests or bacteria, by the action of the active substances contained in the biocidal product. This regulation aims to improve the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.
The text was adopted on 22 May 2012 and will be applicable from 1 September 2013, with a transitional period for certain provisions. It will repeal the Biocidal Products Directive (Directive 98/8/EC).
Polymeric Parts Labelling
Car manufacturers have a legal obligation to label plastic and rubber parts covered by the following standards above the following weight thresholds:
| ISO Reference | Material Type | Weight threshold for labelling |
|---|---|---|
| ISO 1043, ISO 11469 | Unfilled and filled thermoplastics | >100g |
| ISO 18064 | Thermoplastics, Elastomers | >100g |
| ISO 1629 | Rubbers | >200g |
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