Chemical product safety and sustainability

Legal bases

Materials intended to come into contact with food must not transfer ingredients to food in quantities likely to endanger human health or unacceptably alter the odor and taste of the food.

Under the most unfavorable foreseeable conditions of use (temperature, duration of contact, type of food), substances may only migrate up to a certain total amount (global migration) and each individual substance (for example, metal ions or monomers) may only migrate up to the specific migration limit (SML). For plastics, these requirements are regulated in Regulation (EU) No. 10/2011, which was last amended by Regulation (EU) 1245/2020.

The principles of "good manufacturing practice" (GMP) must be observed. For this purpose, in addition to Regulation (EC) No. 2023/2006, a guide was published by the ZVEI that summarizes the requirements, such as the three-stage declaration of conformity.

Recommendations for the implementation for further materials, e.g. silicones, have been published by the BFR:

Health assessment of food contact materials

Recommendations on food contact materials

On September 23, 2020, the revised regulation for food contact plastics (EU 2020/1245) came into force. The regulations regarding food contact products have been tightened.

For you as a manufacturer, it is important to have a competent partner at your side for all your questions here. The experts of the VDE Institute provide you with their extensive knowledge so that you are always on the safe side with your products as far as the currently applicable directives and regulations are concerned.

The most important changes to the revised Regulation EU 2020/1245 at a glance:

• Revision of the list of authorized substances in the EU 10/2011
• Establishment of new restrictions for metals and PAAs
• Updates to the Declaration of Conformity and the Conformity Assessment (including more detailed information to be included in the Declaration of Conformity for substances subject to risk assessment).
• Establishment of new rules for migration testing of equipment and articles for repeated use
• Revision of standard conditions for overall migration testing.

We support you in being able to capture and implement the requirement set out in the revised regulation in order to best prepare your product for market entry.

In § 33, the directive contains a candidate list of substances of very high concern or SVHC. It is managed and updated by the EU. Any supplier’s product that contains a candidate list substance in a concentration greater than 0.1 percent (w/w) by weight must provide the customer with information about the product, e.g. the name of the SVHC substance.

According to the ECJ’s ruling, the individual products that make up the item must be separately evaluated. Each “item” (e.g. electronic product) consists of several components, which are also deemed an item. If the components contain more than 0.1% of a SVHC substance, it must be reported in the entire item. If the total amount of a SVHC substance exceeds one ton per year, the ECHA (European Chemicals Agency) must be informed.

The VDE Institute assists manufacturers and importers in determining the substances from the SVHC candidate list and creates a detailed study report. You are provided with the information within a short period of time, and with the usual premium quality, since the studies are conducted using the products alone, without the aid of additional information, such as product-specific documentation or information from suppliers.

Substance prohibitions according to REACH, Annex XVII
Substance prohibitions on 104 substances; such as nickel in jewelry, PAK or phthalate; were adopted from the former 76/769/EU directive.
As an extension to this, the EU introduced a threshold value for carcinogenic PAK, 1 mg/kg for consumer products, and 0.5 mg/kg for toys. Proven compliance with the requirements is an integral part of the VDE mark. As such, you can sell your product to the best of your knowledge, and your customers can safely use it.

The following substances are part of the carcinogenic PAK family:

• Benzo[a]pyrene
• Benzo[e]pyrene
• Benzo[a]anthracene
• Chrysene
• Benzo[b]fluoranthene
• Benzo[j]fluoranthene
• Benzo[k]fluoranthene
• Dibenzo[a,h]anthracene

Substances requiring approval according to REACH, Annex XIV
Other than in approved, exceptional cases, substances that are listed in Annex XIV of REACH may no longer be used for production in Europe.

These include, for instance, the following substances:

• 1,2-Dichloroethan
• HBCD (Hexabromocyclododecane)
• Bis(2-ethylhexyl) phthalate (DEHP)
• Benzyl butyl phthalate (BBP)
• Dibutyl phthalate (DBP)

The conformity evaluation process is the responsibility of the manufacturer and includes the creation of the required technical documentation along with internal production control that complies with Module A of Resolution 768/2008 of the European Parliament and the Council on a common regulatory framework for the marketing of products. The CE mark is issued according to the general rules set forth in Article 30 of ordinance (EC) 765/2008. It is subject to market monitoring. Severe sanctions may be issued if abused.

The following products are affected by the restrictions:

• Machines
• Lighting products
• Electric tools
• Entertainment technology, information and telecommunications technology devices
• Household devices
• Industrial and non-industrial monitoring and control systems
• Medical devices
• Toys, leisure and sports equipment

On July 2019, the directive’s requirements will then apply to nearly every electronic device.

Many of the user-related exceptions are time-limited and will only be extended individually upon request.

The restricted substances include

• Lead and lead compounds
• Cadmium and cadmium compounds
• Mercury and mercury compounds
• Sechswertiges Chrom
• Two types of brominated flame retardants (PBB and PBDE)

Starting in 2019, short-chained phthalates DEHP, BBP, DBP and DIBP will be included in the RohS directive.

Assessing products and processes in the supply chain
Analytical processes provide information on whether there are substances that are prohibited by law. In conjunction with manufacturer declarations and quality assurance agreements, these test certificates within the supply chain serve to verify a device’s RoHS compliance.

Analysis on homogeneous tools includes low-cost and prompt testing for the presence of the regulated substance via an overview method (screening). In case of a positive result, its exact contents are verified using a specific process.

We offer you an integrated and reliable assessment of RoHS conformity as part of product testing and certification. This helps immensely in achieving legal certainty. To do so, use the following options:

Assess the manufacturer’s documentation (Level 1)
Verify the documents that certify RoHS compliance in the supply chain (such as manufacturer declarations, quality assurance agreements, analytical results, general terms and conditions) and create a final declaration of compliance.

Product testing/analysis (Level 2)
Analysis on components and devices and create a RoHS confirmation of conformity for your product.

Product testing/analysis with conformity monitoring (Level 3)
Analysis on components and devices with yearly conformity monitoring and the issuance of a RoHS certificate for your product, including use of the VDE RoHS label.

Appraisal according to the IECQ process (Hazardous Substance Process Management)
We appraise the management processes for RoHS compliance as per IECQ regulations and, upon the fulfillment of conditions, confirm that the company in question has developed and implemented a process management system for avoiding hazardous substances for the products it manufactures and/or markets.

The VDE online database improves your market presence
The products that we certify as RoHS-compliant are published on our website at www.vde.com/zertifikate. Manufacturers, retailers and buyers regard RoHS compliance as an integral part of selecting a product. Therefore, you can use our offering on RoHS evaluation of products and their entry into the VDE Institute’s information platform website, which is well-known in the field of electrical engineering.

Our laboratory is one of the handful in the world that is accredited according to DIN EN ISO/IEC 17025 regarding global RoHS test standard IEC 62321 and has played a crucial role in standardizing this IEC test procedure. As such, the VDE environmental laboratory is an important institution for chemical studies worldwide, including the VDE environmental laboratory in China (Foshan).

China RoHS
An expansion of the China RoHS has been taking place since July of 2016. It applies to all EEP (electrical & electronic products). This definition of the product scope complies with EU RoHS (DC < 1500V & AC < 1000V). The parts of a product that contains the 6 RoHS substances in excess of the threshold value in homogeneous material must be marked with an X in the material documentation and the other with an O. Devices that do not contain any substances must be marked with a green “e”. If substances are present, the products must be labeled with the “environmental protection use period” product life cycle, the date of manufacture, and the material details in the product documentation.

The VDE Institute performs a material declaration at the level of the homogeneous materials or at the product level. Customer-specific requirements, such as substance and material lists along with legal foundations, are the basis for the tests. We use the “VDE MaDE” software tool to create material declarations in machine-readable form according to IPC175X as you need it.

Benefits for you

We provide you with information on full product composition with regard to your requirements in a short time and with premium quality. But we do not need any preliminary information to do so – a product provided to the VDE Institute is sufficient. This product information will allow you to obtain the qualification for market readiness. Furthermore, you can use the results during supplier evaluations and draw conclusions about their quality. We can evaluate your entire production process and even incorporate the management system.

After your products are tested and analyzed in the VDE Testing and Certification Institute’s chemical laboratory, the results can be transferred to DXC Technology’s Compliance Data Exchange (CDX) system . Importing into CDX is quick and easy via the IPC 1752 format, in which the VDE’s test results will be provided to you. The CX offers a communications platform through which you can share VDE test results with your suppliers and/or customers. Furthermore, additional analyses can be performed or several test results can be aggregated to an end product. In CDX, you can also review your product’s compliance with many different environmental regulations, such as conflict minerals, EVL, HKC, REACH, RoHS or WEEE, and the results can be sent through the entire supply chain.

In addition to creating the material declaration in IPC (*.xml) format, we can also handle data maintenance in the CDX database for products we test on behalf of the customer.

Our tests provide information on your product’s recyclability. In this manner, we document compliance with product disassembly requirements to meet certain recycling quotas. Furthermore, we test mandatory disassembly steps on your product for the removal of critical materials. At the same time, evaluating the individual products provides information on the entire product category’s recyclability.

Our service offering:

• Evaluating your product’s recyclability at the level of recycling-friendly units as per IEC/TR 62635:2012-10
• Checking the plastic part’s mark as per ISO 11469:2000
• Calculating the product’s recyclability and evaluating it according to the guidelines of the WEEE Directive (2012/19/EU) for optimized, minimal and regulatory disassembly
• Calculating recyclability according to EPEAT

Our documentation provides you with additional information on how you can improve your product’s structure with respect to ErP Directive 2009/125/EC.

At the same time, we can create product-specific CO2 balances. The report is created according to PAS2050 and ISO 14040. And the foundation for it is Directive 2009/125/EC “Establishing a framework for the setting of ecodesign requirements for energy-related products” (ecodesign directive).

We evaluate all phases of the product levels: manufacturing, transport, use and recycling. This provides you with approaches for improving the product structure according to ecodesign guidelines. Future product generations can be improved through comparisons of many different product concepts. Furthermore, this comprehensive approach allows for a comparison of many different product locations, packages and transport options.

You can use our results for marketing activities and to support your company strategy on environmentally friendly products. This is because VDE-tested products indicate safety and open markets.

As such, existing problems can be traced back to the level of the materials used. For instance, this gives you an additional argumentation basis for disputes with suppliers and customers.

At the same time, our focus is on the following possible problems:

• Aging plastics
• Defective solder joints
• Flux residues
• Verifying material identity
• Corrosion
• Material defects
• Contamination

We are your reliable partner in many other Areas:

• Researching materials that come into contact with food (LFGB requirements)
• Quality check for test water
• Leaching tests for nickel (Ni) and heavy metals (Cadmium Cd, Lead Pb etc) from electronics and consumer goods

imds professional is a full-service materials compliance company for the automotive industry, particularly for the International Material Data System (IMDS) and the China Automotive Material Data System (CAMDS). imds professional offers comprehensive service and consulting worldwide for ELV, IMDS, CAMDS, REACH and conflict minerals, among others. Furthermore, a wide range of training courses for these topics are available as public seminars, webinars and exclusive in-house training sessions.