European Directives - Safety of Component Materials
REACH
CE Directive 1907/2006
Safety of Chemicals in Europe
The REACH directive (Registration, Evaluation, Authorisation, and Restriction of Chemicals) is one of the European Union’s most important regulations for the management of chemicals.
The main objective of REACH is to ensure a high level of protection of human health and the environment by regulating the production and use of chemicals. Introduced in 2006, REACH requires manufacturers and importers to register chemicals with the European Chemicals Agency (ECHA) and to assess the risks associated with their use.
ECHA is responsible for assessing the hazardousness of chemicals and classifies the most critical ones as SVHC (Substances of Very High Concern). These substances, which are considered to be particularly hazardous, are placed on a candidate list that includes over 200 substances and is published on the ECHA website.
Among these substances are:
- Carcinogenic
- Mutagenic
- Toxic to reproduction
- Bioaccumulative
- Persistent in the environment
- Endocrine disruptors
What does the REACH Directive regulate?
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) is the Regulation (EC) No 1907/2006 that aims to ensure a high level of protection of human health and the environment from chemicals. It states that industry has a responsibility to manage the risks associated with chemicals and to provide information on the safety of the substances it produces, uses or places on the market.
The REACH regulation works through four main processes:
Registration:
manufacturers and importers must provide detailed information on the chemicals they produce or import, such as the percentage contained, hazard and other relevant characteristics.
Evaluation:
ECHA and Member States review the registered information to assess the potential risks associated with chemicals, particularly for those considered to be of concern.
Authorisation:
Certain substances of very high concern, such as those that are carcinogenic or persistent in nature, may be authorised for specific uses, but only in exceptional cases and subject to strict controls.
Restriction:
Hazardous substances may be restricted or banned altogether if the risks associated with their use are deemed unacceptable.
REACH requires that all chemicals produced or imported in quantities above one tonne per year are registered and assessed for their potential risks. This involves collecting detailed information on the characteristics of substances, including data on their composition, physicochemical properties and possible harmful effects.
The evaluation process includes analysis of the health and environmental effects of substances, and provides for risk management measures through the adoption of preventive and mitigating actions. REACH also promotes the substitution of hazardous substances with safer alternatives wherever possible, thus stimulating innovation and the development of more sustainable chemical technologies that can reduce the risk to workers, consumers and the environment.
How SIMEL Complies with REACH
SIMEL is committed to complying with the REACH directive by limiting the use of hazardous substances in its products. We have implemented strict material selection procedures and work closely with our suppliers to ensure compliance with all chemical registration and evaluation requirements. In addition, we take measures to reduce the use of substances of particular concern, thus ensuring minimal impact on health and the environment.
A concrete example of this is the removal of the compound MCCP (chlorinated C-14-17 alkanes), a medium-chain chloroparaffin that was previously present in some of the components it used, such as electrical cables. These cables have been replaced with others that do not contain this substance, without compromising the quality and safety of the product.
European Directives - Material Safety of Components
RoHS
Directive 2011/65/EU
Restriction of Hazardous Substances in Electrical Equipment
La direttiva RoHS (Restriction of Hazardous Substances) 2011/65/UE del Parlamento Europeo regola l’uso di sostanze pericolose nelle apparecchiature elettriche ed elettroniche (AEE). L’obiettivo principale di RoHS è garantire la tutela della salute umana e dell’ambiente, limitando l’uso di sostanze dannose nelle apparecchiature e assicurando che i rifiuti elettronici vengano recuperati e smaltiti in modo ecologicamente corretto. La direttiva RoHS si applica a numerose categorie di AEE, tra cui elettrodomestici, apparecchiature informatiche, dispositivi di illuminazione e giocattoli elettronici.
What does the RoHS Directive regulate?
RoHS imposes specific restrictions on the use of a number of hazardous substances, including lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), all of which are known to have a negative impact on human health and the environment. The directive stipulates that these substances must not be present in homogeneous EEE materials in concentrations above a certain threshold. The regulation also aims to promote innovation by pushing manufacturers to find safer alternatives for the design of their products.
The RoHS directive applies to several types of equipment, including monitoring and control instruments, medical devices, industrial machines and consumer devices. However, there are exceptions, such as equipment intended for research and development, large stationary equipment, and military devices.
Substance or group of substances
Description
Maximum threshold of presence
Type
Cadmium/Cadmium compounds (Cd)
Cadmium is a toxic heavy metal that can cause serious health problems if ingested or inhaled.
0.01% of article weight
⚙️
Lead/Lead compounds (Pb)
Lead is known to be harmful to the nervous system, kidneys and other organs.
0.1% of article weight
⚙️
Hexavalent chromium is carcinogenic and can cause lung and skin damage.
0.1% of article weight
⚙️
Mercury/Compounds (Hg)
Mercury is highly toxic and can damage the nervous system and internal organs.
0.1% of article weight
⚙️
Polybrominated biphenyls (PBB)
These substances are used as flame retardants in electronic products and can accumulate in the environment.
0.1% of article weight
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Polybrominated diphenyl ethers (PBDEs)
Similar to PBBs, PBDEs are used as flame retardants and can be harmful to human health.
0.1% of article weight
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This substance is a plasticiser used in plastics and may have adverse effects on reproductive health.
0.1% of article weight
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Benzil butil ftalato (BBP)
Un altro plastificante utilizzato in materiali plastici, noto per essere tossico per la riproduzione.
0.1% of article weight
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Dibutyl phthalate (DBP)
A third plasticiser that can affect reproductive health.
0.1% of article weight
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Diisobutyl phthalate (DIBP)
Yet another plasticiser, with similar effects to the other phthalates mentioned above.
0.1% of article weight
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The Four Main Obligations of the RoHS Directive
Prevention:
The Directive aims to prevent the use of hazardous substances in EEE placed on the market, including spare parts intended for repair, reuse and improvement of the functional capacity of equipment. This ensures that the equipment is safe for the environment and for human use.
Conformity Assessment:
Producers must demonstrate that their EEE complies with the requirements set out in the Directive. This involves the preparation of technical documentation to prove that banned substances are not present beyond the permitted limits.
Market Surveillance:
EU Member States are responsible for ensuring that EEE on the market complies with the requirements of the Directive. This is done through checks and inspections of equipment.
CE marking:
To demonstrate compliance with EU regulations, manufacturers must affix the CE marking to their products. This mark certifies that the EEE complies with all applicable European directives, including RoHS.
How SIMEL Complies with the RoHS Directive
SIMEL is committed to strict compliance with RoHS regulations. Our company has gradually reduced the use of hazardous substances in its motors and electronic components, adopting alternative materials that comply with the limits imposed by the directive.
Simel works closely with suppliers to ensure that all parts used in our products comply with European regulations, thus contributing to a safer and more sustainable environment. In addition, we continuously monitor our production processes to identify further opportunities to reduce environmental impact, in line with the requirements of the RoHS directive.
European Directives - Safety in Component Materials
SCIP Database
Transparency on Substances of Concern in Products
SCIP (Substances of Concern In articles as such or in complex objects) is a database established under the Waste Framework Directive to collect information on Substances of Very High Concern (SVHC) contained in articles or in complex objects. This database aims to improve transparency and management of hazardous substances in products, contributing to the protection of human health and the environment.
What does the SCIP Database collect?
SCIP collects information on SVHC substances present in articles or complex objects when their concentration exceeds 0.1% by weight. This tool is closely linked to REACH, as substances in the SCIP database are identified through REACH, although REACH does not make direct reference to the SCIP database.
Obligation to Notify the SCIP Database
The notification obligation concerns all suppliers of articles placed on the market in the European Union containing SVHC substances in concentrations above 0.1%. These suppliers include manufacturers, assemblers, importers and distributors, who must provide detailed information to the SCIP database.
What Information Must Be Submitted?
- Article Identification: Data allowing identification of the specific article.
- Substance Details: Name of substance, concentration range and location within the article.
- Safe Use Information: Data allowing safe use of the article and information on its proper handling once converted to waste.
Accessibility of Information
The information in the SCIP database is publicly accessible and is published by ECHA (European Chemicals Agency) on its website, thus promoting transparency and environmental responsibility of products available on the market.