Material Compliance Guidline
Specifications for compliance with legal product requirements
1. Introduction
The purpose of this guideline is to ensure the environmentally compatible and occupationally safe handling of substances and products in the development and production, use, recycling and disposal of the resulting intermediate and end products. It describes the requirements of neoom regarding all known prohibited, regulated and declarable substances in current form.
The material compliance requirements are equivalent to the other product requirements.
The necessity of procuring the respective current laws, standards and directives remains unaffected by this and continues to apply as the supplier's duty to collect. The supplier's obligation to comply with legal requirements (e.g. national laws) is not affected by this guideline. Where there is a difference between this guideline and other legal, normative, customer-specific or other requirements, the stricter specification shall always be applied.
neoom requires that all products or product parts, product packaging and transport materials supplied to it comply with the requirements of this directive.
Each supplier undertakes to comply with this guideline. Compliance with these requirements is the responsibility of the supplier. Suppliers are also obliged to provide, free of charge, the material information required to verify compliance with the legal requirements and these guidelines.
The supplier is obliged to regularly check whether the guideline is available in an updated form. With the amendment of the guideline, it replaces the previous version and is valid with immediate effect. neoom will not notify the supplier of any changes to the guideline.
neoom makes the Material Compliance Guideline available via its website at https://www.neoom.com
Legal notice
Should any legal regulations or changes to the law not be reflected in this guideline, this does not release the supplier from the obligation to take these into account and to comply with the current, applicable legal requirements.
Compliance with this neoom Material Compliance Guideline as an explicit product feature is a contractual component of the cooperation with neoom and the corresponding supply of products. In the event of noncompliance with this guideline, the product concerned and the product delivered to neoom shall be defective. In this case, the supplier is liable for all direct and indirect damages and costs, as well as any consequential costs incurred.
2. Terms and Abbreviations
Product
In this guideline, product is understood to mean everything:
- that is supplied to neoom and remains in a (complex) product that is placed on the market by neoom
- that is supplied to neoom as an auxiliary production material (this also includes the supplier’s operating and auxiliary materials)
- that is passed on to neoom as packaging to be passed on to external customers
- for use as equipment used within the company
Examples of products are:
- Complete products including merchandise
- Modules
- Components
- Raw materials
- Semi-finished products
- Mixtures
- Substances
- Materials
- Packaging including conditioning such as desiccants or corrosion protection agents
- Articles
- Transport materials
Substance
A chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition (cf. REACH Regulation (EC) No. 1907/2006, Art. 3 para. 1).
Mixture
A mixture or solution composed of two or more substances (cf. REACH Regulation (EC) No. 1907/2006, Art. 3 para. 2).
Article
An object which during production is given a special shape, surface or design which determines its function to a greater degree than does its chemical composition (cf. REACH Regulation (EC) No. 1907/2006, Art. 3 para. 3).
Restricted substances
Prohibited substances must not be contained in articles, components, materials, preparations and auxiliary and operating materials above the limit values specified in this guideline. These substances may only be present as natural impurities, they may not be added intentionally. Impurities with these substances shall be indicated qualitatively.
Substances subject to declaration
Substances classified as declarable are not desired in some applications and must be declared above the specified limit values. The listed substances must be indicated for each article, component, material, substance preparation, auxiliary or operating material. Content limits are specified for the individual substances in the document.
CAS number
The CAS number (CAS Registration Number/CAS Registry Number, CAS = Chemical Abstracts Service) is an international designation standard for chemical substances. There is a unique CAS number for each chemical substance registered in the CAS database (also biosequences, alloys, polymers).
SVHC
Substances of Very High Concern are substances that are listed in the candidate list of the European Chemicals Agency (ECHA): http://echa.europa.eu/en/candidate-list-table
Critical raw materials
According to the EU Commission’s definition, critical raw materials are all those raw materials that fulfil two parameters: economic relevance and the supply risk of the substance, which exists when a large share of global production is concentrated in a few countries. More information on critical raw materials can be found at the following link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0474&qid=1614778196868
Homogeneous material:
A material of uniform composition throughout or a material consisting of different materials which cannot be broken down or separated into individual materials by mechanical processes such as unscrewing, cutting, crushing, grinding and sanding (cf. RoHS Art. 3 Para. 20). Examples of homogeneous materials are individual types of plastics, ceramics, glasses, metals, alloys, synthetic resins and coating.
Sunset date
After this date, the placing on the market and use of a substance listed in Annex XIV of the REACH Regulation is prohibited unless an authorisation has been granted.
SCIP database
(Substances of Concern in Products, dt.: „Besorgniserregende Stoffe in Artikeln“) Database to supplement the notification and reporting obligations under the REACH Regulation.
CMRT
(Conflict Minerals Reporting Template, dt.: „Berichtsvorlage Konfliktmineralien“) Free, standardised reporting template for the transmission of information on the origin of potential conflict minerals within the supply chain
3. Obligations for suppliers
Every supplier who supplies to neoom products according to the definition of this guideline is obliged to:
- Know the current status of the legal requirements with all applicable substance restrictions, to comply with them and, if necessary, to obtain the current guideline, law or standard itself.
- Acknowledge and comply with this guideline in the course of the existing business relationship
- Provide neoom free of charge with the product information required to verify compliance with the legal requirements and this guideline and to store the requested material data information (declarations) completely and correctly in the online communication platform “DataCross” provided for this purpose
- Fulfil their information obligations within the supply chain and to include sub-suppliers accordingly
- Not use prohibited ingredients in a concentration above the limit value in the delivered product (if the prohibition cannot be complied with, the contained amount of the prohibited substance must be reported to neoom immediately). Declarable substances in supplied products must be reported to neoom, stating the material, substance name and percentage by weight
- Check at least every 6 months whether the Material Compliance Guideline is available in an updated form. Any amendment to the Material Compliance Guideline replaces the previous version and is valid with immediate effect
The material compliance requirements regulated in this guideline are to be regarded as an explicit product feature and are equivalent to other product requirements.
In individual cases, the technical data sheets of all raw materials and auxiliary materials used must be submitted to neoom for initial sampling on request, or this information must be made available via the online platform provided for this purpose. neoom reserves the right to carry out tests and laboratory examinations on products in individual cases to check compliance with banned substances.
neoom suppliers will not be notified of any changes or versioning of this guideline.
If neoom engages third parties to verify compliance with the legal requirements and this guideline, and to obtain product information accordingly, the supplier’s specified information obligations are also to apply equally to this third party.
Materials and raw materials of unknown origin and/or composition or raw materials of which sufficient material data are not available must not be used without consulting neoom International GmbH.
3.1. Causes for a product declaration by suppliers
A declaration by the supplier for products supplied to neoom is required as soon as one of the causes listed below occurs:
- Product is sampled or delivered for the first time.
- Declarations were not previously available or were incorrect.
- Substances and/or manufacturing processes have been changed.
- New/changed substance bans and/or substance declaration obligations apply and the products supplied are affected by this.
- neoom makes an individual request for declaration
4. neoom – prohibited substances and substances to be declared
4.1. Substance regulations and bans – Necessary for all products
The substance law requirements described under point 5.1 apply to all substances, mixtures and articles. The context of application is described in detail in the corresponding law.
4.1.1. Regulation (EC) No. 1907/2006 REACH – Annex XIV – List of substances subject to authorization
Regulation (EC) No. 1907/2006 (in short “REACH”) entered into force on 01/06/2007. REACH Regulation (EC) No. 1907/2006 is the European Chemicals Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals. The regulation applies to all products supplied to neoom as defined in this guideline.
Annex XIV generally prohibits the use of certain SVHC candidates. The inclusion of a substance from the list of substances of very high concern in Annex XIV of the REACH Regulation leads to an authorisation requirement for this substance at the end of the procedure. After a transitional period, the substance may only be used with an authorisation or its use is prohibited.
You can access the current Annex XIV of the REACH Regulation at the following link: https://echa.europa.eu/en/authorisation-list
If the products supplied to neoom contain any of the substances listed in Annex XIV, this must be reported to neoom immediately.
4.1.2. Regulation (EC) No. 1907/2006 REACH – Annex XVII – List of restricted substances
Annex XVII of the REACH Regulation regulates or bans specified substances in individual/legislatively defined uses.
You can access the current Annex XVII of the REACH Regulation at the following link: https://echa.europa.eu/en/substances-restricted-under-reach
The products supplied to neoom must comply with the specifications in Annex XVII of the REACH Regulation.
4.1.3. Directive 2011/65/EU-RoHS
Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive) came into force on 2 January 2013.
The substance restrictions of the RoHS Directive refer to the maximum concentrations in the homogeneous material of each article.
Substance groups |
Maximum concentration in the homogeneous material in percent by weight (w/w) |
Cadmium und Cadmium compounds |
0,01 % |
Hexavalent Chrom (Cr6+) and Cr6+ compounds |
0,10 % |
Lead and lead compounds |
|
Mercury and mercury compounds |
|
Polybrominated diphenyl ether (PBDE) |
|
Polybrominated biphenyls (PBB) |
|
Di(2-ethylhexyl)phthalate (DEHP) |
|
Butyl benzyl phthalate (BBP) |
|
Dibutyl phthalate (DBP) |
|
Diisobuty lphthalate (DIBP) |
Annex III of the RoHS Directive regulates exemptions for certain uses. These exemptions are divided into categories and time limits apply. If an exemption is used in accordance with Annex III of the RoHS Directive, neoom must be notified.
All products supplied to neoom must comply with the RoHS Directive.
4.1.4. Chemicals Prohibition Ordinance (ChemVerbotsV)
The Ordinance on prohibitions and restrictions on the marketing of dangerous substances, preparations and articles under the Chemicals Act is an Austrian law that prescribes specific national requirements in addition to the REACH Regulation. Since REACH applies as a regulation directly in the EU Member States, the Chemicals Prohibition Ordinance 2003 – with the exception of a few paragraphs – was repealed with the entry into force of the EU Chemicals Law Amendment Regulation 2017, Federal Law Gazette II No. 179/2018. Only those regulations remain that are not covered by Annex XVII of the REACH Regulation and are thus not harmonised under Union law.
All products supplied to neoom must comply with the requirements of the Chemicals Prohibition Ordinance.
4.1.5. Regulation (EC) No. 2019/1021 on persistent organic pollutants (POPs)
This EU Regulation implements, among others, the Stockholm Convention on Persistent Organic Pollutants. The Stockholm Convention, also known as the POP Convention, is an international agreement on binding prohibition and restriction measures for certain persistent organic pollutants. Currently, the Convention bans or restricts the production, use and trade of 22 hazardous chemicals.
Further information on the Stockholm Convention can be found on the official website at: http://chm.pops.intl
4.1.6. Product Safety Act 2004 (PSG)
The Product Safety Act 2004 is the central legal regulation for the safety of consumer products that are not subject to any special regulation – such as there is for electrotechnical products or machines. The Product Safety Act transposes the General Product Safety Directive 2001/95/EC into Austrian law.
An overview of the valid directives of the European Union in the provision of products can be found on the website: https://ec.europa.eu/growth/single-market/ce-marking/manufacturers/
By affixing the CE mark and the accompanying signed CE Declaration of Conformity, the manufacturer, importer or distributor of a product declares, among other things, the conformity of the product with all harmonised standards applicable in the EU for this product.
4.2. Substance regulations and bans – Necessary for products from different areas of application
In contrast to the substance regulations in section 5.1, here the supplier must check whether their products fall within the scope of the respective requirement. If the supplier is unable to clarify this matter independently, they must consult neoom.
4.2.1. Directive 2006/66/EC – Battery Directive
Directive 2006/66/EC of the European Parliament and of the Council of 6 September 2006 on batteries and accumulators and waste batteries and accumulators, and repealing Directive 91/157/EEC restricts the use of mercury and cadmium in batteries and accumulators.
Pure substances |
Maximum concentration in the article in percent by weight (w/w) |
Restrictions on use |
Mercury and mercury compounds |
0,0005% |
Batteries and accumulators |
Cadmium and cadmium compounds |
0,002% |
Device batteries and accumulators |
All batteries and accumulators supplied to neoom must comply with the requirements of Directive 2006/66/EC (EU Battery Directive).
4.2.2. Directive 94/62/EC – Packaging Directive
Directive 94/62/EC of the European Parliament and of the Council of 20 December 1994 on packaging and packaging waste restricts the concentration of heavy metals in packaging.
Pure substances and groups of substances |
Maximum concentration in packaging or packaging components in percent by weight (w/w) |
Lead, cadmium, mercury and chromium VI |
0,01 % cumulative |
All packaging, regardless of the material, must comply with the specifications of the EU Packaging Directive 94/62/EC.
4.2.3. Biocidal Products Regulation (EU) No. 528/2012
Regulation (EU) No. 528/2012 on the supply and use of biocidal products on the European market entered into force on 1 September 2013. With this regulation, the authorisation of biocides is uniformly regulated in the European Union and takes place in a staged procedure.
Every neoom supplier is obliged to fully comply with the specifications and obligations for the following products:
- Biocidal products
- Treated articles
The valid Regulation on the supply and use of biocidal products can be found on the EUR-Lex platform of the European Union by quoting the document number as described in point 8.1. of this guideline: http://eur-lex.europa.eu/
All products supplied to neoom that have been treated with biocides must comply with the requirements of the regulation and be reported to neoom.
4.3. Substances subject to declaration
Article 33 of the REACH Regulation requires each supplier to do the following:
(1) Any supplier of an article containing a substance meeting the criteria of Article 57 and identified in accordance with Article 59(1) in a concentration higher than 0.1% by mass (w/w) shall provide the recipient of the article with the information available to him which is sufficient for the safe use of the article, but shall at least indicate the name of the substance concerned.
The official, current SVHC candidate list according to REACH can be found online at: https://echa.europa.eu/candidate-list-table
This applies to ingredients of very high concern (SVHC candidate list) in
- components
- spare parts
- accessories
- packaging
As far as the delivered articles contain substances of very high concern (SVHC) in a proportion of more than 0.1% by weight, which are published in the so-called candidate list according to Art. 59 para. 1 of the Regulation 1907/2006/EC, the contractor is obliged to provide all information according to Art. 33 para. 1 of the Regulation 1907/2006/EC together with the delivery without being asked. This also applies if such a substance is only included in the candidate list during the ongoing supply relationship.
According to the decision of the European Court of Justice, the concept of "once an article, always an article" applies. As soon as an article exceeds the concentration limit of 0.1%, the presence of this SVHC candidate substance must be communicated throughout the supply chain.
Since 2021 it is obligatory for European companies to register articles with SVHC candidates in the SCIP database of the European Chemicals Agency (ECHA) in addition to the Article 33 (1) and (2) communication. We recommend every company to communicate the SCIP IDs for the registered articles with the European customers. (see chapter "Material data communication according to IEC 62474“)
4.3.1. Conflict Minerals (CM) – Dodd-Frank Act
Under the US Dodd Frank Act, Section 1502, companies in the manufacturing industry must disclose to the Securities and Exchange Commission (SEC) the origin of 3TG minerals (tin, tantalum, tungsten and gold) in their products if they originate from the war zone in and around the Democratic Republic of Congo (DRC). The five critical requirements of the conflict minerals reporting process are:
1. determine applicability: are 3TG minerals present in products or components?
2. appropriate country of origin verification: do the 3TG minerals originate from a conflict region?
3. due diligence: for 3TG minerals from the region around the Democratic Republic of Congo, due diligence must be conducted throughout the chain of responsibility 1
4. Determine status: Determine conflict mineral status at supplier, component and product level.
5. reporting: meeting reporting requirements to SEC and customers.
Suppliers are therefore required to declare whether and, if so, which of the specified 3TG minerals are contained in their supplied goods and, if so, to indicate their origin. These declarations can be made informally or with the help of the CMRT.
For cobalt and mica, please use the EMRT accordingly. The templates can be downloaded here:
https://www.responsiblemineralsinitiative.org/reporting-templates/cmrt/
https://www.responsiblemineralsinitiative.org/reporting-templates/emrt/
4.3.2. Critical raw materials according to Ecodesign Directive 2009/125/EC
Due to Commission Regulation (EU) No. 2019/1784 of 1 October 2019 implementing the ecodesign requirements for welding equipment pursuant to Directive 2009/125/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for the setting of ecodesign requirements for energyrelated products, a presence of critical raw materials in all products supplied to neoom must be declared.
In 2011, the European Commission published a list of critical raw materials (CRMs) for the first time as part of the EU Raw Materials Initiative. This is updated at least every three years. Currently, 30 critical raw materials and groups of critical raw materials are listed.
Due to the current requirements of Regulation (EU) No. 2019/1784, neoom is directly affected by the product groups placed on the market. This means that the declaration of critical raw materials is required for all products supplied to neoom, regardless of the product group.
More information on critical raw materials can be found at the following link: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52020DC0474&qid=1614778196868
If the products supplied to neoom contain any of the current 30 critical raw materials in excess of 1g per component, this must be reported to neoom immediately.
4.3.3. Proposition 65 – Safe Drinking Water and Toxic Enforcement Act, 1986
The Safe Drinking Water and Toxic Enforcement Act, 1986 (also known as California Proposition 65) is a California law enacted in 1986 that promotes clean drinking water. It is also intended to prevent carcinogenic substances and substances that can cause deformities from entering consumer products.
“No person shall, in the course of his or her business, knowingly or unknowingly, expose others to a chemical that, based on current knowledge, may cause cancer or result in neonatal birth defects without providing consumers with clear, conspicuous and reasonable information about that risk.” ‒ California Proposition 65, The Safe Drinking Water and Toxic Enforcement Act, 1986.
The state of California has identified more than 900 such substances. If companies include one of these 900 substances in their products, they must provide a “clear and unambiguous warning” if a person may come into contact with the substance.
The supplier is obliged to provide information on Proposition 65 listed substances or to communicate the necessary warnings for the products supplied. This will allow neoom to comply with its obligation to display warning labels on products intended for export to California.
Further information can be found at: https://oehha.ca.gov/proposition-65/proposition-65-list
If the products supplied to neoom contain any of the listed substances, this must be reported to neoom immediately.
4.4. Hazardous substances
4.4.1. Safety data sheets (SDS)
The safety data sheet is the central element of communication in the supply chain for hazardous substances and mixtures. It provides important information on the following characteristics:
- Identity of the product
- Occurring hazards
- Safe handling
- Prevention measures
- Measures in the event of danger
- Storage and disposal
The requirements for the content and format of the safety data sheet are laid down in Article 31 and Annex II of REACH Regulation (EC) No. 1907/2006. The supplier of a substance/mixture is responsible for ensuring that the safety data sheet is technically correct and completed in full.
The safety data sheet will be provided to neoom free of charge on paper, in electronic form or as a download option no later than the day of the 1st delivery.
Suppliers update the SDS without delay (cf. REACH Regulation (EC) No. 1907/2006, Art. 31 (9)) if
- New information is available that may have an impact on risk management measures.
- An authorisation has been granted or refused.
- A restriction has been imposed.
The corrected version must be made available to neoom if it has been supplied within the last 12 months
5. Summary of the requirements of this guideline
Abbrevation |
Title |
Description |
REACH |
Regulation (EC) |
European Chemicals Regulation concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals |
RoHS |
Directive |
Directive on the restriction of the use of certain hazardous substances in electrical and electronic equipment |
ChemVerbotsV |
Austrian Chemicals Prohibition Ordinance (“ChemikalienVerbotsverordnung“) |
Ordinance on prohibitions and restrictions on the marketing and placing on the market of certain substances, mixtures and products under the Chemicals Act |
POPs Regulation |
Regulation (EU) |
Ordinance on persistent organic pollutants |
PSG |
Austrian Product Safety Act |
Product Safety Act implementing the Machinery Directive 2006/42/EC and the Low Voltage Directive 2014/35/EU relevant here |
EU Battery Directive |
Directive |
Directive on batteries and accumulators and waste batteries and accumulators |
EU Packaging Directive |
Directive |
Directive on packaging and packaging waste |
Biozid Products Regulation |
Regulation (EU) |
Regulation concerning the placing on the market and use of biocidal products |
Conflict minerals |
Dodd-Frank |
Section 1502 Dodd-Frank Act: Reporting of minerals used from conflict areas |
Critical raw materials according to EU Ecodesign Directive |
Directive |
Directive establishing a framework for the setting of ecodesign requirements for energy-related products |
California Proposition 65 |
Safe Drinking Water and Toxic Enforcement Act of 1986 |
Regulation in the US state of California requiring information on chemicals known to the state to cause cancer or to cause birth defects and other reproductive toxicity |