Regulations and Requirements for Compliance Declarations

We’d like to provide you with an overview of the most important current legal regulations for material compliance. By adhering to these regulations, you not only improve the quality and safety of your products but also make a significant contribution to sustainability.

Compliance with the requirements in the field of Environmental Product Compliance (EPC) involves a wide range of laws and regulations. These include environmental and social requirements that govern or even prohibit the use of certain substances and materials in products.

RoHS

REACH

TSCA

PROP. 65

POPs

PPWD

Battery Directive

AfPS

RoHS serves as a regulation for the restriction of certain hazardous substances in various devices. The aim of this regulation is to make the recycling process of problematic components of electronic waste more transparent and thus simplify it. Comparable directives are the Korea and China RoHS, which apply in the Asian region.

The material-specific requirements of the RoHS (Restriction of Hazardous Substances) regulation restrict the use of lead, cadmium, chromium (VI), mercury and brominated flame retardants in electrical equipment and electronic components. The directive requires manufacturers to provide technical documentation for assessing the RoHS conformity of electrical equipment with regard to the restriction of hazardous substances.

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Since July 22, 2019 the RoHS Directive 2015/863/EU has been in force, in which a total of 10 substances must be taken into account, which must not exceed the maximum permissible concentration of 0.1 percent by weight. In addition, the CE marking directive is a mandatory component.

The REACH Regulation (EC) No. 1907/2006 stands for “Registration, Evaluation, Authorization and Restriction of Chemicals”. As an EU regulation, REACH defines the handling of chemical substances equally in all member states. Furthermore, it takes into account the so-called “Candidate List of Substances of Very High Concern (SVHC)”, which has been updated on 08 July 2021 with eight additional hazardous chemicals. This SVHC list is also used in the EU database “SCIP”, which became effective on January 2021.

In 2007, the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) regulation for the first time established the mandatory disclosure of material information for defined chemical substances. The system operates on the principle of “no data, no market”. Accordingly, only those chemical substances may be introduced to the market that have previously been registered by all users of a supply chain within REACH.

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The REACH candidate list is also known as SVHC (Substances of very high concern). This includes chemicals in the form of individual substances or articles that have serious effects on human health or the environment. The direct and legal obligation regarding requirements for all EU suppliers and manufacturers of a supply chain are usually updated every 6 months. Last amended 17th January 2023 expands the number of groups of substances of concern from 224 to 233 hazardous chemicals.

The newly added substances are:

The Toxic Substances Control Act (TSCA) is a key standard of U.S. chemical regulation. The intent is to lower the chemical risk as easily as possible while still considering the benefits of the product.

TSCA is a U.S. Environmental Protection Agency measure against persistent, bioaccumulative, and toxic (PBT) chemicals, which are subject to prohibitions and restrictions on manufacture, further processing, and distribution. All chemicals on the list are considered “existing.” All non-listed chemicals are designated as “new” and are evaluated and regulated prior to marketing. Only substances known to exist within TSCA may be imported into the U.S. under this regulation.

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Folgende Chemikalien sind hiervon betroffen:

The California Safe Drinking Water and Toxic Enforcement Act (Prop. 65) requires California companies selling the goods there to warn consumers about hazardous substances by means of an appropriate label. In addition, the law prohibits the introduction of significant amounts of listed chemicals into drinking water.

The California Proposition 65 regulation is officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986. It requires the state of California to list all chemicals that cause deformities, cancer or other reproductive harm. In addition, all companies are required to label products containing significant amounts of these chemicals. This is considered a warning to the people of California.

All of the chemicals listed have been managed by the California Office of Environmental Health Hazard Assessment (OEHHA).

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The list is constantly being expanded with further substances and threshold values. The last update took place on December 17th, 2021, where the following chemicals were added:

Persistent organic pollutants refer to chemical substances that are difficult to degrade once released and thus remain in the environment over the long term. They also offer the potential for long-range export. This creates the risk of these substances spreading worldwide through air and ocean currents.

Persistent Organic Pollutants (POPs) are chemicals that can have harmful effects on human health and the environment by propagating through food chains in adipose tissue. Due to the potential for global spread, these substances represent a threat to both industrialized but also emission-free regions, such as the Arctic. Examples of these POPs are pesticides (DDT), industrial chemicals (PCBs), diocins and furans.

Stockholm Convention:

Since the entry into force of the agreement to comply with the bans or restrictions on scheduled substances on May 17, 2004, the aim is to protect human health and the environment from adverse effects. The ban or restriction applies to the production and use, import or export of the listed chemical substances.

The “Packaging and Packaging Waste Directive” stands for the handling of packaging and packaging waste. The aim is to reduce packaging waste in order to improve the environmental balance and to support the recycling process in a sustainable manner. In addition, this uniform regulation should contribute to the harmonization of the different measures in the member states. This regulation applies equally in all EU countries.

The Packaging and Packaging Waste Directive specifies the types of packaging that have to be allowed to circulate on the EU market as well as how the waste is managed and avoided as best as possible. In this context, all packaging must meet the requirements in terms of production, composition and reusability/recyclability.

The regulation covers all materials and packaging from industry, commerce and households. On the one hand, the aim is to reduce the increasing amount of packaging waste, which is responsible for significant environmental problems. On the other hand, the regulation aims to uniformly adapt different approvals and regulations in the respective EU countries, thus eliminating an obstacle to the internal market.

In summary, “Packaging and Packaging Waste Directive” regulates:

According to the latest amendments, measures to prevent the new generation of packaging products have been added, as well as provisions to promote reuse and the recycling process instead of the final disposal of waste. By the end of 2024, all EU countries are to ensure that systems have been put in place to comply with this directive.

Battery Directive refers to measures regarding the entire life cycle of batteries and used batteries that are intended to benefit the environment and the internal market. A distinction is made between three different types of batteries: Portable, industrial and automotive batteries.

The Battery Directive aims to minimize all negative environmental impacts caused by batteries and used batteries as far as possible, to maximize the separate collection of used batteries and to achieve a high level of recycling. In addition, the regulation should lead to making batteries and the activities throughout the life cycle of all stakeholders more environmentally friendly. It also aims to reduce the amount of hazardous substances contained in the battery. In this regard, batteries can be classified into three types depending on their intended use: Portable, industrial and automotive batteries.

The Battery Directive has been applied equally in all EU member states since 2006. This is intended to ensure the seamless functioning of the internal market and avoid distortions of competition due to differing regulations. The deadline for member states to implement the directive was September 26, 2008. In 2018, a study commissioned by the Commission found that all countries had implemented the measures.

Measures to achieve the set goals are the following:

Battery Act (BattG):

The German Battery Act (BattG) refers to the European Battery Directive (BATT) which regulates the distribution, return and environmentally friendly disposal of batteries and accumulators. It is independent whether the battery is installed in a device or not. Batteries are categorized into the same three categories as in the Battery Directive (portable, industrial and automotive batteries).

It is mandatory for the distributor or importer to register the batteries with the EAR Foundation before they are offered for sale for the first time. In addition, there is a regular reporting obligation. All batteries must have a correct labeling, which provides mandatory information for the end user. Batteries with particularly hazardous substances below the limit must also have special markings.

The GS label is awarded for compliance with the Committee for Production Safety (AfPS) tested safety specification with regard to polycyclic aromatic hydrocarbons (PAHs) in polymer samples. Compliance with the approved determination limit of PAH contamination on contact/grip and actuation surfaces is tested.