Material Compliance Specification
1. Introduction
The purpose of this Material Compliance Specification is to ensure the legally compliant composition and use of substances, mixtures and articles in development, manufacture, trade, and use.
This Material Compliance Specification describes the requirements of the company JENZI regarding all legally restricted and declarable substances in current form.
If changes to the law are not yet part of this specification, this does not release the supplier from his obligation to take these changes into account and to comply with the current, applicable legal requirements.
The supplier is obliged to obtain the respective current laws and standards himself.
Material Compliance Specification requirements apply equally with all other product requirements.
This Material Compliance Specification requires that all products and their packaging comply with the requirements of current laws and standards to ensure that products are placed on the market in compliance with regulations.
Substances, mixtures, articles, and items of which sufficient material information is not available must not be used.
Upon request, the material information of all substances, mixtures, products, and articles used as well as packaging must be submitted to the JENZI company for inspection and the latter reserves the right to carry out laboratory tests in individual cases.
The supplier of JENZI is obliged to provide the required material information free of charge.
The supplier is obliged to store the requested material data information in the DataCross platform.
The supplier is obliged to check at least once a year whether the Material Compliance Specification is available in an updated form. With the amendment of the Material Compliance Specification, this replaces the previous version and is valid with immediate effect. The supplier will not be notified by JENZI of any changes to the Material Compliance Specification.
The company JENZI provides the Material Compliance Specification online.
This Material Compliance Standard was prepared by tec4U – Solutions GmbH, Saar-Lor-Lux-Strasse 13, D-66115 Saarbruecken. Use and/or reproduction of the standard is permitted to the company and the participants in the supplier chain. For any use of the standard, in whole or in part, outside the supply chain, permission must be obtained from tec4U – Solutions GmbH.
2. Terms, abbreviations, sources
Substance:
means 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. Regulation (EC) No. 1907/2006 Art. 3 para. 1).
Examples of substances:
• organic: ethanol, aldehyde
• metallic: iron, copper, tin
• mineral: clay, loam
Mixture:
means a mixture or solution composed of two or more substances (cf. Regulation (EC) No. 1907/2006 Art. 3 Para. 2)
Examples of mixtures:
• Batch: Seed
• Mixture: Alloy
• Solution: Octane in gasoline
Homogeneous material:
means one material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes (cf. EU Directive 2011/65/EU Art. 3 Par. 20).
Examples of homogeneous materials:
• Plastic
• Ceramics
• Glass
• Alloy
• Coating
Intentionally added:
Im Allgemeinen bekannt als die absichtliche Verwendung eines Stoffes, welcher in einem Erzeugnis enthalten ist, um eine bestimmte Eigenschaft, Aussehen, Funktion oder eine bestimmte Qualität zu erzeugen.
Contamination:
The addition or presence of chemicals to or in another substance to such an extent that it becomes unsuitable for its intended purpose.
Battery:
means any device delivering electrical energy generated by direct conversion of chemical energy, having internal or external storage, and consisting of one or more non-rechargeable or rechargeable battery cells, modules or of packs of them, and includes a battery that has been subject to preparation for re-use, preparation for repurposing, repurposing, or remanufacturing. (cf. EU Regulation 2023/1542 Art. 3 para. 1).
Portable battery:
means a battery that is sealed, weighs 5 kg or less, is not designed specifically for industrial use
and is neither an electric vehicle battery, an LMT battery, nor an SLI battery. (cf. EU Regulation 2023/1542 Art. 3 para. 9).
Packaging:
shall mean all products made of any materials of any nature to be used for the containment, protection, handling, delivery, and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer. ‘Non-returnable’ items used for the same purposes shall also be considered to constitute packaging (cf. EU Directive 94/62/EC Art. 3 Para. 1).
Packaging components:
Parts of the packaging that can be separated by hand or by simple mechanical operations. Additional elements that are directly suspended or attached to a product and perform a packaging function are considered packaging unless they are an integral part of the product.
Restricted substances:
Restricted substances may not be present as substances, in mixtures or in articles above the applicable limits.
Declarable substances:
The substances classified as declarable are not desirable in some applications and must be declared above the specified limits. The listed substances must be specified for each product, component, material, substance preparation, auxiliary or operating material. Below these limits, the declaration obligation does not apply.
Article:
means 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. Regulation (EC) No. 1907/2006 Art. 3 para. 3).
Application Deadline (Latest application date):
According to Regulation (EC) No 1907/2006, an application for authorization must be submitted by this date (date is at least 18 months before the expiry date) so that the substance can continue to be used (deadline).
For information on the application for admission and the formal process of an application for admission, see:
https://echa.europa.eu/de/applying-for-authorisation
Expiration date (Sunset date):
After this date, the placing on the market and use of a substance listed in Annex XIV to Regulation (EC) No 1907/2006 is prohibited unless an authorization has been granted.
Endocrine Disruptors:
Endocrine disruptors (EDs) are chemicals or mixtures of chemicals that disrupt the natural biochemical mode of action of hormones, causing adverse effects (e.g., disruption of growth and development, negative impact on reproduction, or increased susceptibility to specific diseases).
Persistence (Chemistry):
In biology and environmental chemistry, persistence refers to the resistance of – mostly organic – chemical compounds to chemical-physical and biological degradation.
Sources of supply/help:
Platform for European regulations, directives, and decisions, in all existing versions and official European languages – the year of publication and the publication number must be entered in the search mask:
http://eur-lex.europa.eu/
Support area of the European Chemicals Agency (ECHA):
https://echa.europa.eu/support/guidance
REACH-CLP Biocide Helpdesk – Federal National Helpdesk:
https://www.reach-clp-biozid-helpdesk.de/
REACH Helpdesk – German Federal Environmental Agency:
http://www.reach-info.de
REACH@Baden-Württemberg
https://www.reach.baden-wuerttemberg.de/
Platform for German laws
https://www.gesetze-im-internet.de/
3. Company JENZI – list of legally restricted substances
3.1 Substance restrictions – relevant for all products
The substance law requirements described under this point apply to all substances, mixtures and articles.
3.1.1 Regulation (EC) No 1907/2006 REACH – Annex XIV – List of substances subject to authorisation
The inclusion of a substance from the list of substances of very high concern in Annex XIV of the REACH Regulation leads to an authorization requirement for this substance at the end of the process. After a transitional period, the substance may only be used with an authorization, or its use is restricted.
Explanations of the terms application deadline and expiry date can be found under point 2 Definitions, abbreviations, and sources.
Under the following link you can access the current Annex XIV of the REACH Regulation:
https://echa.europa.eu/de/authorisation-list
3.1.2 Regulation (EC) No 1907/2006 REACH – Annex XVII – List of restricted substances
Annex XVII of the REACH Regulation lists substances that are restricted by the legislator in defined applications.
Under the following link you can access the current Annex XVII of the REACH Regulation:
https://echa.europa.eu/de/substances-restricted-under-reach
3.1.3 Directive 2011/65/EU – RoHS
Directive 2011/65/EU of the European Parliament and of the Council regulates the restriction of the use of certain hazardous substances in electrical and electronic equipment.
The substance restrictions of Directive 2011/65/EU refer to the maximum concentrations in the homogeneous material.
Table 1: Substance restrictions of Directive 2011/65/EU
| Substance groups / substances | Maximum concentration in homogeneous material in percent |
|---|---|
| Cadmium and cadmium compounds | 0,01% |
| Hexavalent chromium (Cr6+) and Cr6+ compounds | 0,10% |
| Lead and lead compounds | |
| Mercury and mercury compounds | |
| Polybrominated diphenyl ethers (PBDE) | |
| Polybrominated biphenyls (PBB) | |
| Di(2-ethylhexyl) phthalate (DEHP) | |
| Butyl benzyl phthalate (BBP) | |
| Dibutyl phthalate (DBP) | |
| Diisobutyl phthalate (DIBP) |
3.1.4 Chemikalienverbotsverordnung – ChemVerbotsV
The Ordinance on Prohibitions and Restrictions on the Placing on the Market of Hazardous Substances, Mixtures and Products under the Chemicals Act is a federal German law that prescribes specific national requirements in addition to Regulation (EC) No. 1907/2006. It additionally specifies the national requirements for the following substances and substance groups:
Table 2: Substance restrictions according to the Chemicals Prohibition Ordinance
| Substances/mixtures |
|---|
| Formaldehyde |
| Dioxins and furans |
| Pentachlorophenol |
| Biopersistent fibers |
The current requirements and the listed exceptions can be found in the text of the law.
http://www.gesetze-im-internet.de/chemverbotsv_2017/index.html
3.1.5 Regulation (EU) No. 2019/1021 – POPs
This EU Regulation implements the Stockholm Convention on Persistent Organic Pollutants. The Stockholm Convention is an agreement on prohibition and restriction measures for certain persistent organic pollutants that are binding under international law. Thus, the Convention prohibits or restricts the production, use, and trade of hazardous substances, mixtures, and articles.
Further information on the Stockholm Convention can be found on the official website at the following link:
http://chm.pops.int/
3.1.6 Produktsicherheitsgesetz (ProdSG)
The Produktsicherheitsgesetz (ProdSG) has been in force since July 16, 2021. It is the central legal regulation for the safety of products.
These may only be made available on the market if they do not endanger health and safety. According to § 3, this is permitted if the listed legal interests according to § 8 (1) are not endangered when used as intended or in a foreseeable manner.
Making available on the Union market shall be equivalent to any supply, whether in return for payment or free of charge, of a product for distribution, consumption or use during a business activity.
https://www.gesetze-im-internet.de/prodsg_2021/
3.2 Substance restrictions – valid for products from different scopes of application
In contrast to the substance restrictions in section 3.1, for the regulations described in this chapter the supplier must check whether his products fall within the scope of the respective requirement. Should it not be possible for the supplier to clarify this matter independently, he must inform company JENZI of this without delay.
3.2.1 Regulation EU (2023/1542) – Battery Regulation 2023
The Regulation on batteries and waste batteries, repealing Directive 2006/66/EC and amending Regulation (EU) 2019/1020 entered into force on August 17, 2023. Annex I of the regulation restricts the use of mercury, cadmium, and lead.
Table 3: Maximum concentration for batteries
| Pure substances | Maximum concentration in article in percent | Application restrictions |
|---|---|---|
| Mercury and it’s compounds |
0,0005% | batteries (in devices and means of transport) |
| Cadmium and it‘s compounds |
0,002% | batteries (in devices and means of transport) |
| Lead and it‘s compounds |
0,01% | portable battery (from the 18.08.2024) |
3.2.2 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.
Lead, cadmium, mercury, and chromium VI compounds shall not exceed a cumulative maximum concentration of 100 ppm by weight in packaging or packaging components.
3.3 Substances subject to declaration
3.3.1 SVHC Candidate List
The current version of the official SVHC candidate list according to
Regulation (EC) 1907/2006 can be found at the following address:
https://echa.europa.eu/de/candidate-list-table
According to Article 33 of the REACH Regulation, each supplier is obliged to the following:
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 greater than 0,1 % by mass (w/w) shall provide the purchaser of the article with the information available to him which is sufficient for the safe use of the article but shall provide at least the name of the substance concerned.
Ingredients of very high concern (SVHC candidate list) in
• Components
• Spare parts
• Accessoires
• Packages
Insofar as the delivered articles contain substances of very high concern in a proportion of more than 0.1% by weight, which are published in the so-called candidate list in accordance with Art. 59 Para. 1 of Regulation 1907/2006/EC, the contractor is obliged to provide all information in accordance with Art. 33 Para. 1 of Regulation 1907/2006/EC with the delivery without being requested to do so. This also applies if such a substance is only included in the candidate list during the ongoing supply relationship.
Private consumers must be provided with this information free of charge upon request within 45 days.
According to the decision of the European Court of Justice, the concept “once an article, always an article” applies. As soon as a (partial) article exceeds the concentration limit of 0.1%, the presence of this SVHC candidate substance has to be communicated.
If you supply articles containing SVHC candidate substances greater than 0.1% by weight, we expect you to submit your SCIP dossier number in addition to your article 33 notification.
3.4 Production Auxiliaries and Operating Materials
3.4.1 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 features:
• Identity of the product
• occurring hazards
• safe handling
• Prevention measures
• Measures to be taken in the event of danger.
The requirements for the contents and format of the safety data sheet are regulated in Article 31 and Annex II of REACH Regulation (EC) No 1907/2006.
The supplier of a hazardous substance or mixture is responsible for ensuring that the safety data sheet is technically correct and complete.
The safety data sheet will be provided free of charge to the company JENZI on paper, in electronic form or as a download option at the latest on the day of the 1st delivery.
Suppliers shall update the SDS without delay (Art. 31 (9)) if
• new information is available that may have an impact on risk management measures
• an approval has been granted or refused
• a restriction was enacted.
The corrected version must be made available to the customer, should the customer have been supplied within the last 12 months.
