Material compliance

from Wikipedia, the free encyclopedia

The material compliance (MC) is concerned with compliance with environmental and international law relevant laws and regulations, religiously motivated specifications and requirements of companies that restrict the use of various substances and / or materials in products or even prohibit.

The majority of the material compliance regulations deal with environmentally relevant aspects of products, which is why the MC is to be seen primarily as a sub-area of ​​product-related environmental protection. Other areas of product-related environmental protection are z. B. the energy efficiency of devices or the pollutant emissions of cars. The requirements that result from product-related environmental protection represent product features (such as the dimensions or the function of the product). If MC product features are not met, the product is simply defective.

Material compliance regulations that have been drafted by lawmakers to date aim to protect people and the environment from harmful substances, prevent the uncontrolled mining of protected wood species and curb the financing of warlords (warlords in crisis areas) through illegal mining.

The legislature is always in conflict: on the one hand, to achieve the above-mentioned social goals, on the other hand, to maintain the productivity of the industry. This means that the legislature must document the hazard for each potentially dangerous substance depending on the application and check what options there are to use less questionable substances (substitution) and in what period of time this can be implemented in an economically justifiable manner.

This leads to a large number of regulations, which in turn have many specific, time-limited exceptions for the respective use of the regulated substances.

Regulations

Regulations refer to laws and regulations as well as norms, standards (e.g. guidelines) and, above all, company specifications.

Examples of environmentally relevant material compliance regulations are: REACH , RoHS , ELV , TrinkwV , Toy Directive , Hong Kong Convention , ElektroG (WEEE) , BatterieG , VerpackG , BizidV, HolzhandelsV, POP Convention , Railway Industry Substance List (RISL) and Food Safety Regulation (EG 1935 / 2004, EU 10/2011 and Consumer Goods Ordinance).

Example of a MC set of rules motivated by international law : Conflict Minerals

Examples of religiously motivated MC requirements (relevant e.g. for machines and systems in food production or for packaging): Kosher and Halāl

Examples of company MC specifications : Bosch N 2580 prohibition and declaration of ingredients and Daimler DBL 8585

Regulated substances and materials

Regulated substances and materials mean over 100 groups of substances, which contain over 3000 substances. For example, lead in its compounds is u. a. regulated in the Electrical and Electronic Equipment Act, which in turn has led to lead-free soldering , among other things .

Products

With products we mean:

  • Substances (chemical elements and compounds)
  • Mixtures (batches, mixtures or solutions)
  • Products (object that is given a specific shape, surface or design during manufacture)

Classification and demarcation

  • Compliance vs. Material compliance : Typical compliance issues are corruption and compliance with tax legislation. However, the topic of material compliance has a direct product reference. It is to be understood as a technical requirement.
  • Hazardous substance management vs. Material compliance : Hazardous substances management deals with the handling of hazardous substances in the workplace and is therefore a sub-area of ​​occupational health and safety. The aim is to reduce the dangers of employees in the workplace and the effects of production on the environment. The MC as a sub-area of ​​product-related environmental protection aims to reduce dangers to the population and the environment that arise from the product itself.

In Europe, the best known material compliance regulations are REACH and RoHS . Worldwide, however, there are over 50 sets of rules that restrict or even prohibit the use of certain substances in products. The MC describes the sum of all these requirements that are relevant for a product. The first task is to find out which sets of rules apply to the product in the various sales markets. The MC can be seen here as a further component of requirements management, the task of which is to define all technical requirements for the product.

Furthermore, the complexity of material compliance results from the large number of regulated substances, differently regulated limit values ​​(which in some cases contradict each other) and many temporary exceptions related to the respective use.

Scope of regulations

Which products fall within which scope of regulations can be a complex issue that, in rare cases of damage, is ultimately clarified in court. Only the competent authorities (central bodies such as stiftung ear & ZSVR , state offices, federal offices) with the appropriate authority can decide which products, substances and companies are affected . Lawyers, consultants, associations and service providers, on the other hand, cannot issue a legally binding opinion. However, they are able to make recommendations and use their practical experience to simplify the declaration for those placing on the market. Regulations that do not refer to products but directly to substances such as For example, the EU chemicals regulation REACH, all products are affected, unless there is a special exception. For most companies in the supply chain, the question of which rules should be observed doesn't even arise, as they oblige their customers to adhere to specific material compliance rules through contractual provisions. These agreements made in this way (for example on the terms and conditions ), however, represent private law, while the regulations considered here are public law. So it comes about that distributors are still held liable, even if obligations for testing, registration, declaration, licensing or registration between the parties have been passed on by contract. When in doubt, the plaintiff also targets several parties in the supply chain. It is theoretically possible to pass on or hand over the requirements from the regulations in this way, but it is legally open to challenge and dangerous, as penalties, sales bans and lawsuits are still threatened.

State of the art

Every company can generally define its state of the art for all technical requirements . In the event of liability, a court will decide what the state of the art is to be observed. It is therefore recommended that companies comply with existing standards.

The DIN EN 50581 and which emerged from IEC 63000 were for the electrical / electronics industry to demonstrate the RoHS guidelines developed. Both standards, however, indicate that they can also be used for other substance-related regulations.

The international material data system represents the state of the art for verifying material compliance in the automotive industry.

Technical implementation according to DIN EN 50581 and IEC 63000

The question in practice is how the product characteristic material compliance can be taken into account in the product development process (PDP) and how the MC is ultimately proven, i.e. measured. When checking the dimensions of a product, for example, there are many measuring methods and the task of quality assurance is to select and apply the measuring method that corresponds to the state of the art. Analogous to this, there is also a state of the art for the MC according to which the MC is to be checked. It is obvious that not every product can be chemically analyzed before it is placed on the market, as this analysis will destroy it. There can be no one hundred percent control because otherwise there would be no more products available for sale. A chemical check of a product from every manufactured batch is usually not feasible for many reasons.

DIN EN 50581 and IEC 63000 know four elements for proof of material compliance. These are:

  • Technical assessment (component risk assessment: how high is the risk that a regulated substance is contained? E.g. organic compounds in metals are not possible) and / or
  • Supplier declaration (confirmation that the amount of restricted substances used is within the limits) and / or
  • Material declarations (information on the amount of specific substances and exceptions applied) and / or
  • analytical test results.

All procedures and results used are to be documented and kept up to date. Supplier declarations on material compliance must always refer to a specific component. In addition, the trustworthiness of the information must be proven. This can e.g. B. be done through an MC supplier evaluation and a component risk assessment. If no trustworthy information is available, an analytical test result is required. This can also come from the supplier. The transfer of fully declared material data in the supply chain (product composition down to the basic substance level) is only standard in the automotive industry (see IMDS ).

Implementation strategies for data generation

If there is a high proportion of in-house production or if the material composition of the products is known (e.g. the CAS number can be researched for standard materials), the following procedure applies:

  1. Generation of fully declared data and comparison with the list of regulated substances.
  2. Inquire only for purchased parts for which no complete data is available (scope: supplier declarations at component level with reference to the respective regulations).
  3. Check the trustworthiness of the suppliers in relation to the MC.
  4. Check how high the risk is that the component contains a regulated substance.
  5. Components for which no trustworthy information is available or for which there is a high MC risk must be chemically analyzed on a random basis.

This procedure is also permitted for subcontractors if the material is specified and checked in the general quality assurance process.

If there is a small proportion of in-house production or if the material composition of the purchased parts is unknown:

  1. Inquire about all purchased parts (scope: supplier declarations at component level with reference to the respective set of rules).
  2. Check the trustworthiness of the suppliers in relation to the MC.
  3. Check how high the risk is that the component contains a regulated substance.
  4. Components for which no trustworthy information is available or for which there is a high MC risk must be chemically analyzed on a random basis.

Technically speaking, the implementation of material compliance is therefore mainly a combination of risk assessment and data management. Obtaining the MC information from the suppliers usually represents the greatest effort.

Liability issues

  • Contract law § 433 Civil Code (BGB): The seller has to provide the buyer with the item free of material and legal defects.

If a customer proves a regulated substance in a product (e.g. by means of a chemical analysis) there is a material defect according to § 433 BGB. There is a risk of recall and claims for damages by customers.

  • Insurance cover does not apply if compliance with the state of the art cannot be proven (due to the test clause).
  • Product liability: In the event of damage, there is still a risk of proceeding under product liability law ( Section 823 BGB and Section 1 ProdHaftG) if compliance with the state of the art cannot be proven.
  • Law enforcement: There is a threat of measures by the authorities, e. B. Section 27b ChemG : "Anyone who violates Regulation (EC) No. 1907/2006 ... (REACH) is punished with a prison sentence of up to two years or a fine."

For criminal prosecution, it is sufficient that a regulated substance is contained in a product without causing any damage. International prison sentences are also threatened for violating product-related environmental protection.

Trigger for the liability case

  • Market surveillance activities triggered by:
  1. Notes from customs
  2. Notification from another authority
  3. Communication or complaint from consumers or consumer protection organizations
  4. Accident or claim
  5. Notes from the relevant industry ("competitor complaint")
  6. Media reports on the dangers or damage to health caused by chemicals
  7. RAPEX notification
  8. Self-motivated samples of market surveillance (market purchases)
  • Activities of customers: with a mass spectrometer analysis, the common regulated substances can be discovered. All major market players conduct their own material compliance risk analyzes for their suppliers and purchased parts

See also

literature

  • John Phyper, Philippe Ducas, Peter J. Baish: Global Materials Compliance Handbook . 2004, ISBN 978-0-471-46739-7
  • R. Dodge Woodson: Construction Hazardous Materials Compliance Guide: Lead Detection, Abatement, and Inspection Procedures . 2012; ISBN 978-0-12-415838-2
  • R. Dodge Woodson: Construction Hazardous Materials Compliance Guide: Asbestos Detection, Abatement and Inspection Procedures . 2012; ISBN 978-0-12-415841-2

Web links

Individual evidence

  1. ↑ Global Automotive Declarable Substance List ( GADSL ), accessed March 1, 2017
  2. ↑ Regulation (EC) No. 1907/2006 of the European Parliament and of the Council (REACH Regulation) acc. Article 3 (1) (PDF) , (file size 1.84 MB).
  3. ↑ Regulation (EC) No. 1907/2006 of the European Parliament and of the Council (REACH Regulation) acc. Article 3 (2) (PDF) , (file size 1.84 MB).
  4. ↑ Regulation (EC) No. 1907/2006 of the European Parliament and of the Council (REACH Regulation) acc. Article 3 (3) (PDF) , (file size 1.84 MB).
  5. ↑ a b c DIN EN 50581: 2013-02; Technical documentation for the assessment of electrical and electronic devices with regard to the restriction of hazardous substances
  6. ↑ Gabi Förtsch, Heinz Meinholz: Handbook of operational hazardous substance management, 2016, ISBN 978-3-658-13087-9
  7. ↑ Collection of MC rules (PDF, 51 kB), accessed on March 1, 2017
  8. ↑ Global Automotive Declarable Substance List ( GADSL ), accessed March 1, 2017
  9. ↑ Regulation (EC) No. 1907/2006 of the European Parliament and of the Council (REACH Regulation) acc. Annex XIV and XVII (PDF) , (file size 1.84 MB).
  10. ↑ § 2 No. 15 of the Ordinance on Hazardous Substances (GefStoffV)
  11. ↑ Kalkar decision of the BVerfG on nuclear law of August 8, 1978
  12. ↑ a b Technical documentation for the assessment of electrical and electronic equipment with regard to the restriction of hazardous substances (IEC 63000: 2016); German version EN IEC 63000: 2018
  13. ↑ International Material Data System (IMDS), accessed on March 1, 2017
  14. ↑ ZVEI guidelines on "Material declarations within the supply chain", accessed on March 1, 2017
  15. ↑ Arun Kapoor: Zeitschrift für Stoffrecht (StoffR) ISSN  1613-3919 , Product Risk Pollutant, StoffR 5 2016 , accessed on March 1, 2017
  16. ^ Noerr law firm: BGH on substance bans under RoHS and ElektroStoffV, accessed on March 15, 2017
  17. ↑ Frankfurter Allgemeine: Manager sentenced to prison term in South Korea, January 6, 2017, accessed on March 15, 2017
  18. ↑ Market surveillance in Baden-Württemberg: Sector-specific market surveillance program for chemical safety 2015–2019 (PDF, 426kB), accessed on March 15, 2017