Best Practices for REACH Compliance

Transcription

1 Best Practices for REACH Compliance Wednesday, May 24, :30 am 9:30 am 1 Your Presenters Today Host: Ammie Grauten Marketing Manager Presenter: Randy Flinders Senior Manager, Product Support 2 1

2 Agenda GreenSoft who we are and what we do REACH Areas of concern for article producers The SVHC Candidate List REACH Annex XIV REACH Annex XVII Changes to the definition of an Article The GreenSoft Advantage a total solution Q&A 3 GreenSoft Technology Who weare and what we do 4 2

3 GreenSoft Overview Established in 2002, GreenSoft Technology is a leader in the field of environmental compliance management Two business branches: Data Management Services:GreenSoft conductsdata collection, validation and conversion to any desired format Software tool:for management and reporting of various environmental regulations, such as RoHS-2 & REACH SVHC & Conflict Minerals, from desktop to LAN-based to Internet-based to cloud-based Extensive experience in collecting, formatting and analyzing electronics and compliance data One-Stop Total Solution Provider: From data collection to product-level compliance reporting Data, software, and reporting solutions for environmental compliance management 5 More About GreenSoft Headquartered in Pasadena, California, USA with offices in Europe, Israel, Japan, Taiwan and China 120 employees Data factory in Shijiazhuang, Hebei, China. 180 miles south of Beijing ISO 9001:2015 certified 6 3

4 Much more than just REACH.. GreenSoft has many years experience in assisting customers with REACH Compliance, but it doesn t stop there. GreenSoft can assist with any environmental compliance requirements. Just some of the requirements we help customers address: 7 REACH Areas of Concern for Article Producers 8 4

5 REACH Areas of concern for article producers REACH is the Restriction and Authorization of Chemicals legislation in the EU. Chemical restrictions, authorization requirements, and supply chain communication requirements for all substances and mixtures imported into or manufactured in the EU. INCLUDES substances present in articles (products). An article that expels a mixture or substance (toner cartridge, ink pen) would need be addressed as both an article and a substance mixture. 9 REACH Areas of concern for article producers Important things to consider when applying REACH requirements to articles such as EEE: Does the article expel any mixtures or substances? Is the article manufactured in the EU or imported into the EU? A clear understanding of the definition of an article is required Which Annex XVII restriction entries apply to your type of product? Regular data updates every 6 months Customer requirements The type of data required by your customers will define what type of data is required from your suppliers 10 5

6 REACH The Substances of Very High Concern (SVHC) Candidate List 11 REACH The SVHC Candidate List Producers of articles must evaluate their product for SVHCs present in the article of sub-articles in amounts greater than 1000ppm. SVHCs present over the stated threshold must be communicated through the supply chain professional customers only. (Not end users.) At a minimum the name of the SVHC present must be provided. If the amount of the substance imported, used, or manufactured in the EU is above 1 metric tonneper year, some official notification requirements may also be triggered. There are currently 173 substances on the list. More substances are added approximately every 6 months. (So any REACH Certification from your suppliers have very short lifespans.) 12 6

7 REACH The SVHC Candidate List Article Definition what is an article and how do we calculate substance concentrations?: AnarticleisdefinedinREACHas 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. The original interpretation of this definition was that an article is an end product. A recent EU Court of Justice decision re-interpreted the definition as one an article, always an article. This means any past REACH compliance validations performed at the product level are no longer viable. Manufacturers need to understand the impact of this change and review their process to ensure they are adequately collecting data at the correct subpart level. 13 REACH The SVHC Candidate List Best Practices for SVHC Compliance Validation: Collect Full Material Declaration (FMD) data when possible. Pay close attention to the use of proprietary substances. Be persistent and be patient with suppliers, and have a processoriented collection process to ensure the quality of collection (comprehensiveness). On average, from GreenSoft s experience in dealing with collection of REACH data from suppliers it takes an average of four iterationsof communications in s or phone calls to obtain valid data and documentation. Be prepared for the amount of resources needed to perform collection. x

8 REACH The SVHC Candidate List Best Practices for SVHC Compliance Validation: Have a data validation process on the required data and documents per your compliance requirements. (Garbage in / Garbage out) Built-to-spec items typically do not have supplier data available, and other processes and strategies need to be defined and deployed in these cases. On average, from GreenSoft s experience in dealing with the data collection for EEMs, data collection and the existing database (over 64M parts) will generate around 80-85% of the parts. Assessment based on materials or drawing files would generate another 7-10% of parts. The remaining would either go through replacements or lab testing. 15 REACH Annex XIV The Authorization List 16 8

9 REACH Annex XIV Annex XIV provides some requirements on certain SVHCs which have restrictions on use applications Annex XIV, while not applicable to articles imported into the EU, is applicable to manufacturers of articles within the EU. The substance must be authorized for its intended use in the article before being manufactured within the EU. Many companies with factories or EMS providers located in the EU are starting to require Annex XIV validation of components from suppliers. Producers of Substances and Mixtures are in scope even if imported from outside the EU. 17 REACH Annex XIV Best Practices for REACH Annex XIV Compliance validation: Collect a combination of FMD and Certificates of Compliance (CoCs) - due to proprietary substances. There is no minimum threshold for use of these substances SVHC declaration CoCis not valid for Annex XIV. Software tool capable of rolling up all component data to the product level. All versions of GreenSoft s GreenData Manager software have complete Annex XIV compliance validation capabilities. GreenData Manager 18 9

10 REACH Annex XVII The Restricted/Prohibited Substance List 19 REACH Annex XVII Annex XVII defines specific substances which are either prohibited from use completely or have restrictions when used in certain predefined applications. The REACH Annex XVII substance list maintained by the European Chemicals Agency (ECHA) is not all inclusive as the regulation refers to the several classes of substances called out in EU regulation (EC) No 1272/2008 (CLP directive) for some restricted substances

11 REACH Annex XVII The Annex includes hundreds of substances as defined by 67 (current) entries to the Annex. Each entry has specific information on scope and applicability. Example 1: Entry 66 restricts BPA, but only in Thermal paper made available after Jan 2, Producers of electronic devices can probably ignore this restriction. Example 2: Entry 23 restricts Cadmium in articles containing certain polymers, and painted articles. This requirement may apply to certain electronic or electrical articles, depending on their construction. Example 3: Entry 29 restricts substances which appear in Regulation (EC) No 1272/2008 (CLP directive) classified as germ cell mutagen category 1A or 1B or mutagen category 1 or 2. If an article (such as a printer ink cartridge) expels any substance that meets this description, it may be non-compliant. Many of the entries do not apply to articles at all. So performing a compliance analysis against the entire Annex XVII is not only very difficult, it is also largely useless without hours of follow up research. 21 REACH Annex XVII Best Practices for Validating product compliance to Annex XVII: Collect a combination of FMD and CoCs-due to proprietary substances. Tool capabilities A software tool is essential. The tool should provide the ability to apply the substance restrictions based on category applicable to the specific product. Due to the number of applicable substances, and varied application scopes, pre-filtering based on entry applicability is important

12 5/24/2017 REACH Annex XVII Best Practices for Validating product compliance to Annex XVII: All versions of GreenSoft s GreenData Manager software have this capability built in. Our team has scrubbed all Annex XVII restricted substances, including substances in (EC) 1272/2008 conforming to stated classifications. The software has detailed rules divided up into 20 usecategories. Simply select the categories applicable to your product/bom, and instantly view the compliance status of your product. Components and parts can be classified by commodity code, so only the Annex XVII restrictions that apply to the component are applied. 23 REACH Annex XVII 24 12

13 Changes to the Definition of an Article A review of the impact to manufacturers of EEE 25 Changes to Article Definition under REACH Background Original Definition Final Article Substance Aggregation at final article (final product) EU Court of Justice decision 10 Sept in case C-106/14 Once an Article, Always an Article Draft Guidance document Version 4.0 has been issued with several updates. Examples of how to calculate the SVHC in an article are provided Few on electronic components See GreenSoft s blog for more info: tinyurl.com/eureachblog 26 13

14 How to deal with the new Article Definition Example 1: Integrated Circuit Step 1: Identify homogeneous materials using existing FMD data: 27 How to deal with the new Article Definition Example 1: Integrated Circuit Step 2: Determine which materials meet the definition of an Article. For materials that do not, determine which article element base they belong to: 28 14

15 How to deal with the new Article Definition Example 1: Integrated Circuit Step 3: Calculate the SHVC compliance status for each article The final SVHC status for Article A (the entire IC) can be aggregated as shown: 29 How to deal with the new Article Definition Example 2: Capacitor Step 3: Calculate the SHVC compliance status for each article The final SVHC status for Article B (the entire cap) can be aggregated as shown: 30 15

16 Best Practices on complying with the new Article Definition Have a process in place to ensure suppliers have evaluated their components for SVHC compliance at the sub-article level. This may require additional information on component construction. Consider communication methodologies for your customers to provide this level of information as well. Evaluation of construction can be complex. For example, how a wire was made determines if the insulation is an article or not. GreenSoft can do this evaluation for you and ensure supplier data is validated to be in accordance with the new article definition. Software Tool: Any software tool used to validate product compliance for REACH SHVC should have the ability to dynamically apply article aggregation bases for each material present in a part. (Article Flags) Note that software cannot determine the article status of materials. This requires human intervention for construction analysis. Our EXPERTS can do this for you! 31 The GreenSoft Advantage Leveraging Excellence 32 16

17 The GreenSoft Advantage GreenSoft offers a customized complete solution for companies of all sizes, markets, and needs. Data Collection:Data collection, validation and management services to manage your entire product and materials base. Software: Various versions to meet your needs: Hosted GreenData Manager Hosted on the cloud, no internal IT involvement. On-Premise GreenData Manager Install your parts database on your servers and have complete control over data security and access. Desktop Edition Inexpensive single-seat option Workgroup Edition Collaborative environment for larger compliance groups Browser Edition Global access to compliance and product data for all global business units Turnkey Product Compliance: Just provide us with your BOM(s) or a parts list and specify the compliance requirements (regulations or rules). GreenSoft delivers compliance reports per your requirements with due diligence documents collected from suppliers. 33 The GreenSoft Advantage GreenSoft Component Database 64 M part numbers from 27,417 manufacturers worldwide Mar 2017 Part Numbers Database: 6.6 M parts with Full Material Declaration (FMD) Data REACH SVHC status and Certificates: SVHC(161) 17M SVHC(163) 1.19M SVHC(168) 997K SVHC(169) 6.92M SVHC(173) 8.05M 34 17

18 The GreenSoft Advantage Why partner with GreenSoft? Existing part database of 64M parts decreases data collection time improving time to market. Leverage the work we have already done! Collection of FMD data allows leveraging across current and future regulations and customer requirements. Only collect CoCs where needed. Avoid future data collection. Data Validation ISO 9001 certified Quality Assurance process ensures 99.9% data quality/accuracy. 35 The GreenSoft Advantage Why partner with GreenSoft? Data Maintenance GreenSoft will maintain your compliance data at a 6 months freshness level always be confident your data is up-to-date! Software With Hosted, Browser, Workgroup, and Desktop editions available, GreenData Manager software is available for every size company and every budget. GreenData Manager offers complete integration with ERP/PLM systems. Software is automatically updated for regulation changes

19 The GreenSoft Advantage Why partner with GreenSoft? Cost GreenSoft estimates the average cost of doing data collection internally is around $46 per part on average of 10K parts ($460,000 total). Outsourcing to GreenSoft costs a fraction of that. GreenSoft s GreenData Manager software offers the best value in the industry, with complete compliance product tracking, analysis, and reporting capabilities starting at a low entry cost

20 THANK YOU!