REACH – RoHS – CMRT – TSCA – PFAS – PROP 65

REACH Regulation

The REACH Regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals) of the European Union, No. 1907/2006 - S.I. No. 2020/1577, is a fundamental pillar in the regulation of chemicals, and its impact extends to the safety valve sector. This legislation, in force since 2007, aims to improve the protection of human health and the environment through a more responsible management of chemicals used in industrial processes, including those present in safety valves.

This regulation imposes a series of responsibilities on companies that produce, import, or use chemicals in the European Union. Among its main provisions, there is the obligation to register chemicals based on the quantity produced or imported and to provide detailed information on the safety and use of such substances. This registration process is crucial for a comprehensive assessment of the potential risks to human health and the environment associated with the chemicals used.

Furthermore, the REACH Regulation provides for the evaluation and authorization of chemicals considered of particular concern to human health or the environment, the so-called SVHCs (Substances of Very High Concern). Such substances may be subject to use restrictions or require special authorization for use, thus promoting the adoption of safer alternatives and reducing exposure to harmful substances.

For companies operating in the safety valve field, compliance with the REACH Regulation represents a significant challenge. These valves often contain materials subject to registration and evaluation under this directive, and companies must ensure compliance with these regulatory provisions along the supply chain. It is essential for companies to be aware of the chemicals present in safety valves and their implications for compliance with REACH.

Compliance with the REACH Regulation is not only a regulatory issue but also a matter of social and environmental responsibility. Ensuring the safety of chemicals used in safety valves not only protects workers and the environment but also helps maintain customer trust and preserve corporate reputation.

The REACH Regulation is a fundamental regulatory tool for the safe management of chemicals in the European Union. Companies operating in the safety valve sector must be aware of REACH provisions and take necessary measures to ensure regulatory compliance, thereby contributing to increased safety and sustainability in industrial processes.

To comply with the Waste Framework Directive 2008/98/EC and waste management provisions, due to the presence of a percentage of lead in safety valves produced by Nuova General Instruments using brass components, the SCIP code 40a69763-e03e-45e8-9529-f625fe219cc0 was issued via the ECHA portal.

Below is a summary table of characteristic materials of safety valves containing SVHC.

Materials	Code	Standard	Lead Percentage	SVHC Limit
CuZn39Pb3	CW614N	UNI EN 12164	2.5% - 3.5%	0.1%
CuZn40Pb2	CW617N	UNI EN 12165	1.6% - 2.5%	0.1%
CuZn42	CW510L	UNI EN 12164	Max 0.2%	0.1%

 

The safety valves produced by Nuova General Instruments comply with the REACH directive, as indicated in Article 7, paragraph 2 of the regulation, since SVHC substances (lead) are used in quantities less than one ton per year during production and/or importation.

RoHS Regulation

The RoHS (Restriction of Hazardous Substances) Directive 2011/65/EU represents a milestone in the regulation of the electronics industry, with an impact that extends to the safety valve sector as well. This legislation, introduced by the European Union in 2002 and updated with EU Regulation 2015/863, aims to reduce the use of harmful substances for the environment and human health in electronic products. This includes safety valves, which may contain materials subject to restrictions such as lead. 

Safety valves are fundamental devices to ensure the proper functioning of systems that use electrical and electronic equipment, subject to the provisions of the RoHS Directive. However, addressing the challenges of compliance with this regulation may require companies to rigorously review their supply chains and production processes. 

The substances currently considered SVHC by the RoHS Directive are as follows:

• Lead
• Hexavalent chromium
• Mercury
• Cadmium
• PBB (polybrominated biphenyls)
• PBDE (polybrominated diphenyl ethers)
• DEHP (di(2-ethylhexyl) phthalate)
• BBP (benzyl butyl phthalate)
• DBP (dibutyl phthalate)
• DIBP (diisobutyl phthalate)

It is essential for manufacturers of safety valves to identify and monitor the use of these substances in their products to ensure compliance with the regulation.

Safety valves produced by Nuova General Instruments comply with the RoHS Directive. The brass material used in some of these safety valves contains lead up to a maximum of 3.5% of the copper alloy (UNI EN 12164 CW614N), thus complying with the provisions of the regulation (Annex III of the directive exempts copper alloys containing up to 4% lead by weight from the restrictions under Article 4, paragraph 1).

Compliance with the RoHS Directive not only contributes to the protection of the environment and public health but also to the company's image and consumer confidence. Companies that adopt ethical practices and comply with environmental regulations can distinguish themselves in the market and demonstrate their commitment to sustainability, environmental protection, and public health.

Conflict Minerals Reporting Template (CMRT)

In an increasingly ethically and sustainability-conscious landscape, the safety valve sector is not immune to such considerations. The need to ensure an ethically responsible supply chain of materials, including the risk of using minerals from conflict-affected regions, has led to the development of the Conflict Minerals Reporting Template (CMRT). This tool, widely adopted by companies in all sectors, including that of safety valves, provides a standardized framework for communicating information about the origin of minerals used in production. Through the CMRT, companies can track and share details about the supply chain, ensuring compliance with international conflict regulations and promoting ethically responsible production.

The adoption of the CMRT in the safety valve sector represents a significant step towards greater transparency and accountability in supply chain management. This not only helps prevent funding of armed groups and human rights violations in conflict-affected regions but also strengthens consumer and investor confidence in the corporate ethics of safety valve manufacturers.

However, it is important to note that implementing the CMRT may present challenges, such as accurately collecting data on mineral provenance and verifying information received from suppliers. Nevertheless, the CMRT remains a valuable tool for promoting ethical traceability in the safety valve supply chain, demonstrating companies' commitment to corporate social responsibility and sustainable production.

In this context, Nuova General Instruments confirms its commitment to transparent and ethical business conduct in the safety valve sector, ensuring the categorical exclusion of the use of materials or minerals from conflict-affected regions.

TSCA-PFAS

The Toxic Substances Control Act (TSCA) and Perfluoroalkyl Substances (PFAS) represent two crucial issues in the regulation of chemical substances and safety valves' safety. The TSCA is a US federal law that regulates the production, importation, and use of chemicals to ensure public safety and environmental protection. PFAS are a class of persistent, bioaccumulative, and toxic chemicals widely used in a range of industrial and consumer products, including safety valves.

The TSCA underwent significant updates in 2016, aiming to strengthen the regulation of chemical substances and improve transparency and access to safety information. These updates included the prioritized evaluation of existing chemical substances, the imposition of stricter requirements for the registration and evaluation of new chemical products, and the promotion of information sharing on safety among federal authorities and industry stakeholders.

PFAS, on the other hand, have become a growing global concern due to their persistence in the environment and potential impact on human health and the ecosystem. These substances may be present in materials used in the production of safety valves, such as rust-proof coatings or special lubricants, and their presence may raise safety and regulatory compliance concerns.

For companies producing or using safety valves, it is essential to understand the implications of TSCA and PFAS on regulatory compliance and product safety. Compliance with TSCA requires the registration and evaluation of chemicals used in products, as well as compliance with reporting and risk management requirements. Regarding PFAS, companies must be aware of potential sources of contamination and take preventive measures to ensure the safety of their products and environmental protection.

Additionally, companies may consider adopting strategies to reduce or eliminate the use of PFAS in their production processes, such as substituting PFAS-containing materials with safer and more sustainable alternatives. This not only contributes to regulatory compliance but also demonstrates a commitment to environmental responsibility and consumer safety.

The Toxic Substances Control Act (TSCA) defines the following list of chemical substances whose use must be regulated:

• Decabromodiphenyl ether (DecaBDE)
• Phenol, isopropylated phosphate (3:1) (PIP (3:1))
• 2,4,6-Tris(tert-butyl)phenol (2,4,6-TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

Safety valves produced by Nuova General Instruments comply with the Toxic Substances Control Act (TSCA) as they do not contain any of the above-described chemical substances. Furthermore, these valves are free of PFAS.

It is important to note that PTFE (polytetrafluoroethylene), a common sealing material used in safety valves, does not fall into the category of PFAS (Perfluoroalkyl Substances). Although both contain fluorine atoms, there are significant differences in molecular structure and chemical properties between PTFE and PFAS.

PTFE is a synthetic polymer also known as Teflon, widely used for its exceptional properties of heat resistance, corrosion resistance, and abrasion resistance. It is commonly used in a wide range of industrial and consumer applications, including gaskets, sleeves, and other components used in safety valves. PTFE is considered an inert and non-reactive substance and is not classified as PFAS.

Proposition 65

Proposition 65, or PROP 65, is a California law aimed at protecting consumers from exposure to chemicals known to cause cancer, birth defects, or other reproductive harm. This law requires that consumers be provided with a warning if a product contains one of these chemicals above certain exposure levels.

For companies operating in the safety valve sector, compliance with Proposition 65 is essential to ensure consumer safety and regulatory compliance. Since safety valves are critical components in a wide range of industrial applications, it is essential that they are made with safe materials free of harmful chemicals.

PROP 65 requires companies to assess their products for the presence of chemicals included in the list of chemicals known to the State of California to cause cancer or reproductive harm. If any of these substances are present in the products, companies must provide a warning to consumers, indicating the risk associated with exposure to such chemicals.

To ensure compliance with Proposition 65, companies in the safety valve sector must conduct accurate assessments of the materials used in the production of their valves. It is important to identify any chemical substances subject to restrictions and take measures to reduce or eliminate their presence in products.

Additionally, companies must be aware of changes in legislation and new chemical substances added to the Proposition 65 list. Maintaining up-to-date knowledge of regulations is essential to ensure ongoing compliance and product safety.

Compliance with Proposition 65 not only protects consumers from exposure to harmful chemicals but can also help preserve the company's reputation and maintain consumer confidence. Companies that demonstrate a commitment to safety and regulatory compliance can distinguish themselves in the market and build trust with consumers.

When considering the use of Nuova General Instruments safety valves for the American market, where Proposition 65 is a mandatory requirement, it is advisable to opt for valves made entirely of AISI316L. This becomes particularly important as Proposition 65 (Safe Drinking Water and Toxic Enforcement Act of 1986) is closely linked to the use of products intended for drinking water, where the use of food-approved materials is essential.