Thule Group Prohibited and Restricted Substances Framework Contents 1 Introduction... 2 2 The P&R Substances Framework... 2 2.1 Prohibited & Restricted Substances List (P&R List)... 2 2.2 Testing... 2 2.3 Authorization... 3 2.4 The P&R list compliance communication... 3 2.4.1 Proactive chemicals management... 3 3 Definitions... 4 3.1 Article... 4 3.2 CAS... 4 3.3 Several... 4 3.4 Limit value... 5 3.4.1 Prohibited (#) or (ND)... 5 3.4.2 Usage range... 5 3.4.3 Extraction vs Total content... 5 4 Annex... 6 4.1 Annex 1 Regulatory compliance... 6 4.2 Annex 2 Testing methods... 8 Thule AB Fosievägen 13, SE-21431 Malmö Sweden P +46 40 635 90 00 F +46 40 635 90 20 info@thule.com www.thulegroup.com Reg no 556770-6329 Registered Office Malmö
1 Introduction The purpose of this document is to introduce the Thule Group Prohibited and Restricted Substances Framework that defines the product compliance with the regulatory requirements and our proactive work to eliminate substances in our products that pose a risk to humans and the environment. The safety of our consumers and the safety of our environment is vital to our success and Thule Group reflects this in the way we conduct our business. The Thule Group Prohibited and Restricted Substance (P&R) list aim is to ensure that every one of our products is safe for our consumers' health and the health of our environment. The Thule Group P&R list contains substances that are prohibited (banned) or restricted (under certain limit value) in our products. 2 The P&R Substances Framework 2.1 Prohibited & Restricted Substances List (P&R List) The Thule Group Prohibited & Restricted Substances List (P&R List) contains Thule Group s requirements for chemical substances in articles, that are inspired by the stringent consumer safety requirements of bluesign BSSL, since we strive to go beyond the legal requirements. The P&R list either exceeds or follows the restrictions and bans for chemical substances specified in the regulations, directives and legal acts mentioned in Introduction s Annex 1. The P&R list has been updated annually. Beside the update of regulatory requirements we utilize the support of the bluesign system and RISE s Chemical group. Compliance with any other regulatory updates of the main legal documents, that can be found in Appendix Q in the P&R list, falls under obligations of our suppliers. Since 2015, Thule Group has been a System Partner to bluesign, an international system for environmentally certified textile production. The system sets and controls standards for an environmentally friendly and safe production. Moreover, the membership in the Chemicals Group at RISE (former Swerea), that focuses on research concerning chemicals in materials and products, gives access to chemical databases and offers support and help in managing legislation. 2.2 Testing Testing shall be conducted by an accredited laboratory, that is accredited for the particular analyse. The testing methods listed in the last column of the P&R list are the recommended ones. The testing methods column consists of two entries: sample preparation, e.g. extraction, digestion, derivatisation, and the test method, e.g. GC-MS, LC-MS, HPLC,etc. Please see details of the testing methods in Annex 2 of this Introduction. Depending on their availability international or national standards are also given for several substances and these methods may be applied. Other accredited methods can only be applied if it can be verified that equivalent results are obtained. 2
2.3 Authorization Authorisation or exception from our stringent P&R list is done on a case-by-case basis when a P&R substance needs to be used in a new product. The exception is granted with a condition usually based on an active dialog with the supplier. The Authorization is documented and followed up by the P&R list committee. An authorisation is NOT granted if doing so would infringe on the law. 2.4 The P&R list compliance communication The Thule Group P&R list is communicated in all of our supplier contracts and utilized internally during all product development, procurement, and quality activities to drive forward proactive efforts to phase out undesirable substances. A variety of methods are used to check compliance, depending on the type of product and material. Some examples are materials declarations and materials specifications from suppliers, International Material Data System (IMDS) analyses and third-party chemical analyses. The Supplier commits to comply with The Thule Group P&R List by accepting the Thule Group Purchase Conditions. It is the Supplier s responsibility to assure compliance with the Thule Group P&R List and to inform all their downstream suppliers and subcontractors about the content of the Thule Group P&R List. Requested limit values and updates of the main legal documents listed in Appendix Q must be followed. If not possible, supplier must inform the Thule Group responsible purchaser and ask for an authorization before proceeding with any deliveries. Any breach of the P&R list shall be considered as delivery of faulty products. At the Thule Group, we want to conduct our business with as little impact on the environment as possible. Therefore, we would like to encourage a more proactive chemicals management within our supply chain. 2.4.1 Proactive chemicals management We want to support suppliers who wish to eliminate and minimise the use of hazardous substances in their products and production processes, before they are included on Thule s prohibited and restricted list of substances (P&R list) or regulated by the law. Thule also encourages suppliers to strive for full material declarations of their products to avoid the need for changes every time a new substance is added to P&R list or due to new regulatory requirements. For textile and accessories suppliers we recommend to adopt the targets of bluesign system to minimize the environmental impact throughout the production process. Substances with certain hazardous properties are more likely to be included on Thule s lists in the future. For example, substances that are identified as SVHC (Substance of Very High Concern) according to the EU REACH-regulation (Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)). In general terms an SVHC is a substance meeting one or more of the following criteria: Class 1 or 2 carcinogen, mutagen, or toxic for reproduction (CMR) Substance which is PBT (persistent, bio-accumulative and toxic) or vpvb (very persistent and very bio-accumulative) in accordance with Annex III of REACH Other substances for which there is evidence of equivalent degree of concern (e.g. endocrine disruptors) 3
Information on whether a specific substance fulfils the SVHC criteria can be found in ECHAs Classification & Labelling Inventory Database: http://echa.europa.eu/information-on-chemicals/cl-inventory-database Here you can search Annex VI to Regulation (EC) No 1272/2008 (Classification, Labelling and Packaging of Dangerous Substances ) in order to determine whether a specific substance is hazardous (e.g. CMR) and has been assigned a harmonized classification, i.e. the classification of a substance is obligatory at Community level. You can also find out if a substance has been identified as a PBT or vpvb substance. It should however be noted that the ESIS database is not complete, and further investigations may need to be undertaken to determine the hazardous properties of a substance according to Annex III of REACH. Substances with endocrine disruptive properties (Chemicals that can interfere with the endocrine, hormone system in mammals) are often not included in chemical databases or Safety Data Sheets, and therefore need to be further evaluated. The European Commission has developed a candidate list of suspected endocrine disrupting chemicals, which can be found here: http://ec.europa.eu/environment/chemicals/endocrine/strategy/being_en.htm In addition, the SIN (Substitute It Now) List, developed by ChemSec (the International Chemical Secretariat) in close collaboration with leading NGOs in the EU and the US, can be used in order to identify substances which may be included on the REACH Candidate List (http://echa.europa.eu/candidate-list-table) in the near future: http://w3.chemsec.org/ 3 Definitions 3.1 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 (fibers, textile fabrics, buttons, zippers, etc.). 3.2 CAS CAS registry numbers are unique numerical identifiers for chemical elements, compounds, polymers, biological sequences, mixtures and alloys. Chemical Abstracts Service (CAS), a division of the American Chemical Society, assigns these identifiers to every chemical that has been described in the literature. The intention is to make database searches more convenient, as chemicals often have many names. Almost all molecule databases today allow searching by CAS number. 3.3 Several Several means, that the whole substance group is restricted although not all substances that are restricted are explicitly listed. The listed examples represent only those substances, which should be considered if substance group is intended for testing. 4
3.4 Limit value The maximum amount of chemical substances permitted in articles for the usage ranges A, B and C. 3.4.1 Prohibited (#) or (ND) Several chemical substances or substance groups are prohibited. For these substances or substance groups intentional use in manufacturing of articles is prohibited. That means that chemical products (e.g. colorants or textile auxiliaries) used for manufacturing of articles must not intentionally contain these substances or substance groups. The aim of the prohibition is to avoid release of harmful substances to the environment and to avoid occurrence in the manufactured article by precautionary principle. Although a chemical substance is Prohibited, residual amounts of this substance may be contained in a product from a not intended source. In this case, a limit in the brackets (#) is defined to minimize these currently unavoidable traces. The prohibited substance must not be detectable above limit value stated in brackets (#) or (ND) not detected. 3.4.2 Usage range Usage ranges classify consumer goods according to their consumer safety relevance. Three usage ranges (A, B, C) are defined with A being the most stringent category concerning limit values/bans: Usage Range A: Next to skin use and baby-safe (0 to 3 years) Usage Range B: Occasional skin contact Usage Range C: No skin contact 3.4.3 Extraction vs Total content Please note the difference among Extraction, Extraction with acid solution and Total digestion. 5
4 Annex 4.1 Annex 1 Regulatory compliance Europe Regulation (EC) No 1907/2006 (REACH Regulation), Annex XVII Regulation (EC) No 850/2004 (POPs Regulation) Directive 2011/65/EU (RoHS 2 Directive) Regulation (EC) No 528/2012 (Biocidal Product) Directive 94/62/EC (EU Packaging Directive) PAH Testing Requirements Amended under GS Mark; Scope: Category 2 Other products Directive 2009/48/EC (Toy Safety), EN 71-3:2013+A1:2014 (Part 3: Migration of certain elements) Americas Consumer Product Safety Improvement Act (CPSIA), version 2008 SOR/2011-17 (Toy Regulation) Dodd-Frank Act - section 1502 (Conflict minerals) Country Specific legislation (bluesign RSL v9.0) 6
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4.2 Annex 2 Testing methods Sample preparation Solvent(s) Temperature ( C) Time (min) Other requirements Extraction with KOH Potassium hydroxide (1M) 90 12-15 hours Derivatisation with Acetic anhydride Extraction with MeOH Methanol 70 60 Ultrasonic bath Extraction with THF Tetrahydrofuran 40 60 Extraction with DCM Dichloromethane 40 60 Ultrasonic bath Extraction with MTBE Extraction with MeOH/Acetonitrile ASE - Accelerated Solvent Extraction Methyl tert-butyl ether Methanol/Acetonitrile (1:1) Acetone/Hexane (1:1) 60 60 Ultrasonic bath 70 30 Ultrasonic bath 100 - ASE Accelerated Solvent Extraction Ethyl acetate 40 - Soxhlet Extraction Acetone/Hexane (1:1) - 480 Headspace - 120 45 DIN EN ISO 105-E04 (2013) Acidic sweat solution 37 60 Textile to liquor ratio 1:50 For headspace measurements a purge & trap gas chromatography is recommended. 8