SCIP – “choose the best approach”
Download as PPTX, PDF0 likes355 views
The SCIP (Substances of Concern In articles as such or in complex objects) initiative requires companies in the EU to report the presence of hazardous substances in their products, as mandated by the EU Waste Framework Directive. Introduced in January 2021, it aims to improve waste management and recycling while ensuring compliance with chemical safety regulations. Presenters at the Future Bridge Conference discussed obligations, notification types, and data submission methods for fulfilling these reporting requirements.
![30
Common Errors (Validation Errors; See SCIP Validation Document)
• [BR731] Non-EU companies are not permitted to submit SCIP notifications.
• Approximately 79,300 attributed incidents.
• A large number of these were identified as coming from legal entities registering ECHA REACH-IT accounts
from locations in Switzerland and Norway, both of which are part of the European Economic Area (EEA)
and not one of the 27 EU member states.
• [BR729] SSN: Same notification cannot be submitted multiple times.
• Approximately 30,700 attributed incidents.
• Repeated submission attempts.
• [BR718] If a SCIP notification is updated, then the updated dossier creation date must be newer
• than the previously accepted dossier creation date.
▫ Approximately 11,900 attributed incidents.
▫ Dossiers need to be generated after each update to the applicable article.
SCIP Database State of Play
Extracted From SCIP IT User Group Meeting on March 25, 2021](https://image.slidesharecdn.com/scip-choosethebestapproachassent1cc-210924142608/85/SCIP-choose-the-best-approach-30-320.jpg)
SCIP – “choose the best approach”
- 1. SCIP – “choose the best approach” Presented at: Future Bridge Conference, September 2021.
- 2. Today´s presenters Raj Takhar Senior Subject Matter Expert, Materials Management & Chemical Reporting Email: Raj.Takhar@Assentcompliance.com Monika Srubarova Senior Consultant Product Compliance Email: m.srubarova@1cc-consulting.com
- 3. Agenda • Background on SCIP Reporting Obligations • SCIP Notification Types • EU REACH Reporting vs ECHA SCIP Reporting • SCIP Database State of Play & Dissemination (Public) Portal • Manual Data Collection & Submission to ECHA SCIP Database • Automated Data Collection & Submission to ECHA SCIP Database • Conclusion “choose your approach”
- 4. 4 Background on SCIP Reporting Obligations 1
- 5. 5 Background on SCIP Reporting Obligations The European Union (EU) Waste Framework Directive (WFD) (2008/98/EC) was updated in 2018, and applies to all products sold in the EU, regardless of manufacturing origin. KEY FEATURES: • Introduced binding targets to reduce waste. • Established a hierarchy for waste processing. • Facilitated waste recovery through decontamination. • Improved EU recycling systems. • Outlined mandatory requirements for a centralized Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database. 2021 5 JANUARY
- 6. 6 • Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database reporting is defined under Article 9 of the EU Waste Framework Directive (WFD) 2018/851: • In 2020, a great deal of debate occurred around the industry belief that the European Chemicals Agency (ECHA)’s SCIP reporting requirements exceed European Union (EU) Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Article 33 reporting. • EU REACH Article 33 reporting requirements were updated via the 2015 European Court of Justice ruling “Once An Article Always An Article.” The text states “pursuant to,” which translates to “in accordance with/similar to.” Background on SCIP Reporting Obligations Understanding the Reporting Obligations
- 7. 7 In early 2020, Article 9(i) was updated via EU member state Competent Authorities for REACH and CLP (CARACAL) meetings: The key change is the use of formats and submission tools provided by ECHA, as opposed to existing EU REACH templates that may exist within industry. Background on SCIP Reporting Obligations Understanding the Reporting Obligations
- 8. 8 As part of the original SCIP stakeholder workshops in 2018, a non-paper was issued by the commission that outlined the need to collect data and established the conceptual “duty holders” that ECHA defined SCIP reporting obligations for: • EU Importers (importing articles that contain SVHCs from non-EU countries), • EU Manufacturers, • EU Assemblers, • EU Distributors. Background on SCIP Reporting Obligations Understanding the Reporting Obligations
- 9. 9 January 5th 2021 was the date specified in the WFD amendment, when the legal obligation to submit information to the SCIP database began. Enforcement is down to the individual member state countries and should be “effective, proportionate, and dissuasive.” Reality Check !
- 10. 10 The SCIP timeline so far Source: echa.europa.eu
- 12. 12 The EU WFD mandates that any products containing SVHCs must have new part and substance data created in Article Data Sets. Article Data Sets are used to create SCIP dossiers. The data in these SCIP dossiers is either sent to downstream customers in the form of a declaration or registered in the SCIP database, if you are the Duty Holder/Importer of Record. New obligation came into force on January 5, 2021 — duty holders have an obligation to register their products with the European Chemicals Agency (ECHA) and continue to maintain the data in real-time. SCIP Notification Types
- 13. Storage Data Submission Manual Preparation Online SCIP Notification Types How Data Is Submitted SCIP Database Publication of the Information as Received (duty holder responsibility for submitting accurate data) Duty Holders (Article Suppliers) System to System Source: https://echa.europa.eu/documents/10162/24205171/wfd_database_presentation_en.pdf/ Manual Upload of File Dissemination
- 14. • Individual product/complex product information. • Compiled using SCIP mandatory and/or optional data reporting fields. • Updated as new data is known (additional SVHCs/products containing SVHCs/SVHCs removed from products). • Once data is compiled: • SCIP Article Notification submission freezes data and generates .i6z file for article(s) record. SCIP Notification Types • Snapshot of a article dataset at a point in time (based on SCIP Article Notification submission .i6z file created). • Not linked dynamically to dataset. • Created to generate final .i6z package, which is then submitted to the ECHA submission portal as a dossier. • Unique submission ID generated per dossier submitted. ARTICLE DATASETS DOSSIERS IUCLID SUBMISSION Portal
- 15. 1. Create lower level Article records for Articles that contain SVHCs 2. Create Assembly level Article records. 3. Create the Complex Article dataset and reference Assembly Level Article records and lower level Article records. 4. Create Complex Article Dossier and submit all records in one SCIP Submission. SCIP Notification Types Start with lowest level article records Complex Article Dataset Assembly Level Article Record(s) Lower-Level Article Record(s) With Detailed SCIP Information Lower-Level Article Record(s) With Detailed SCIP Information
- 16. Source: ECHA SCIP IT User Group July 15, 2020 SCIP Notification Types Complex Article Dataset Assembly Level Article Record(s) Lower-Level Article Record(s) Lower-Level Article Record(s)
- 17. SCIP Notification Types EU Legal Entities (LE) The obligation to provide information to ECHA starts with the first supplier (producer/importer). Initial SCIP Notification Reference SCIP Notification Simplified SCIP Notification (SSN) Downstream Users of original SCIP notified articles, who produce higher level complex articles, which in turn generate new SCIP notifications. Distributors who move articles as received, making no changes. Retailers and other supply chain actors supplying articles directly and exclusively to consumers are not covered by the obligation to provide information to the SCIP database. Non-EU Supply Chain Foreign Users
- 18. SCIP Notification Types ▪ Make safe, efficient waste stream decisions. ▪ Support compliant reuse of materials. ▪ Improve efficiency of recycling programs. ▪ Empower informed choices. ▪ Improve targeted disposal. ▪ Monitor SVHCs to assess regulatory actions. ▪ Support waste policy decisions. ▪ Support enforcement. SCIP Database Source: https://echa.europa.eu/documents/10162/24205171/wfd_database_presentation_en.pdf/ Waste Operators Authorities Competitors, Consumers & Other Interested Parties
- 19. 19 The end point of your REACH SVHC obligations/management is the starting point for WFD SCIP efforts/obligations. Obligations under WFD/SCIP are prescriptive, granular, and dynamic. The dossier submission has to reflect the article mapping of the product as placed on the market. Reality Check !
- 20. 20 Reporting is aligned to the ECHA SCIP Dissemination and Confidentiality Document. • This document identifies steps to protect Confidential Business Information when making SCIP Article dataset and Dossier submissions. • Legal entity names are not displayed. • SCIP Article Notifications are not searchable at the article level (they are only displayed for referenced articles within an Article Dataset and dossier submission. • Table 1 is key to understanding how data is displayed at the complex and simple article levels. The SCIP Dissemination (Portal) is a publicly facing database. • 4.2 Million SCIP Article Notification data loaded initially from over 6,000 companies • Reduced dataset from actual number of SCIP article notifications (10 Million +). SCIP Dissemination (Public) Portal What can be searched for
- 21. 21 The SCIP Dissemination (Portal) is accessible from: https://echa.europa.eu/scip-database Current design loads all 4.2 Million + records allowing users to navigate the entries records or search against specific criteria: • Article Identifiers (article name, brand, model, EAN, etc). • Article Categories (EU Taric Code). • Mixture or Material Categories. • Substance of Concern (Candidate List Substance Name). • Reason for Inclusion (As per candidate substance entry). SCIP Dissemination (Public) Portal What can be searched for
- 22. 22 Clicking onto the details screen will open up a factsheet view with detailed data SCIP Dissemination (Public) Portal Factsheet View (Simple Article)
- 23. 23 SCIP Dissemination (Public) Portal Factsheet View (Complex Article)
- 24. 24 EU REACH Reporting vs. ECHA SCIP Reporting 3
- 25. 25 EU REACH 1907/2006 (New Article Context) • Manufacturers and importers of articles have to adhere to the three substance lists (Candidate/Authorisation/Restricted). • Under Article 33, when a Candidate List substance is identified, companies are required to report to downstream users when it is present above the 0.1 percent threshold at the article level (the lowest article level within a complex article). Current practice is to list the SVHCs at the article- as-sold level, at minimum. Additional safe-use information is optional. EU REACH Reporting vs. ECHA SCIP Reporting Different Use Cases EU WFD 2018/851 (Recycling & Recovery) • Focus on Candidate List SVHCs. • Follows “Once an Article, Always an Article.” • Additional data points: • Clear identification of where the SVHC is located in a product structure. • Article category (tariff codes). • Safe use: Updated in October 2020 to cover normal use and whole life cycle use (broader than EU REACH – not released in normal use context). • Clear identification of how the SVHC arrived in the article (mixture/material form). Update datasets and dossiers ONLY when new data is known (additional / removed SVHCs)
- 26. SCIP database reporting follows both EU REACH 1907/2006 Article 33(1) reporting and the European Court of Justice September 2015 “Once an Article, Always an Article” ruling. This means you cannot list a single finished complex article with a list of SVHCs underneath it as a single SCIP submission. EU REACH Reporting vs. ECHA SCIP Reporting Follow EU REACH + ECJ 2015
- 27. 27 SCIP Database State of Play 4
- 28. 28 Registered Legal Entities in REACH-IT for SCIP • 2,984 legal entities registered at the end of January 2021. • 3,600 legal entities registered on March 15, 2021. • 6,000 + legal entities registered by May 2021 Number of SCIP Article Notifications Submitted • 7 million SCIP Article Notifications by the end January 2021. • Nearly 10 million SCIP Article Notifications on end of May 2021. SCIP Database State of Play Extracted From SCIP IT User Group Meeting on March 25, 2021
- 29. 29 Methods of Data Transmission Source: echa.europa.eu Types of SCIP Article Notifications Submitted This statistic shows that companies are either: • Submitting on behalf their non-EU supply chains. • Submitting ahead of their EU supply chain making their applicable SCIP notifications and referencing supplier SCIP article notification numbers.
- 30. 30 Common Errors (Validation Errors; See SCIP Validation Document) • [BR731] Non-EU companies are not permitted to submit SCIP notifications. • Approximately 79,300 attributed incidents. • A large number of these were identified as coming from legal entities registering ECHA REACH-IT accounts from locations in Switzerland and Norway, both of which are part of the European Economic Area (EEA) and not one of the 27 EU member states. • [BR729] SSN: Same notification cannot be submitted multiple times. • Approximately 30,700 attributed incidents. • Repeated submission attempts. • [BR718] If a SCIP notification is updated, then the updated dossier creation date must be newer • than the previously accepted dossier creation date. ▫ Approximately 11,900 attributed incidents. ▫ Dossiers need to be generated after each update to the applicable article. SCIP Database State of Play Extracted From SCIP IT User Group Meeting on March 25, 2021
- 31. 31 Most notified product categories • machinery and their parts; • measuring instruments and their parts; • electronic equipment and their parts; • vehicles and their parts; • articles made of rubber; and • furniture. SCIP Database State of Play Most reported substances • Lead, • Lead monoxide, • Diboron trioxide, • 4,4'-isopropylidenediphenol, • Lead titanium trioxide. Source: echa.europa.eu
- 32. Manual Data Collection & Submission to ECHA SCIP Database 5
- 33. 34 1cc guides you through the jungle of regulatory requirements worldwide
- 34. 1cc AT A GLANCE GEOGRAPHIES • EU, Eastern Europe, Middle East • North and South America • Selected countries in Asia-Pacific and Africa LANGUAGE CAPABILITIES • Arabic, Chinese, Croatian, German, English, Estonian, French, Hungarian, Hebrew, Italian, Polish, Russian, Serbian, Spanish, Turkish and Twi LOCATIONS • 1cc GmbH, Stuttgart / Germany (headquarter) • 1cc Corp., Dallas, TX / USA
- 35. Manual Data Collection & Submission to ECHA SCIP Database 1. Understand your individual obligation 2. Understand your scoped product 3. Supply Chain communication 4. Data preparation 5. Data submission & maintaince
- 36. 1. Understand your individual obligation CHALLENGES ACROSS INDUSTRIES • Actors waiting for the implementation into their national law • Companies closed during pandemic • User account per legal entity • Responsibility ends up on one person, not run as a project • Internal training
- 37. 2. Understand your scoped product CHALLENGES ACROSS INDUSTRIES • Identifying out of scope products • Understanding of an article definition • “Once an article, always an article”
- 38. 3. Supply chain communication CHALLENGES ACROSS INDUSTRIES • Non EU suppliers or local suppliers do not understand the obligation / regulation itself • Many suppliers closed during pandemic • Supplier training • Data are received in different ways • Poor quality of data received • No plausibility check of data received • New SVHC twice a year • Every 6 months new request are communicated throughout supply chain Source: echa.europa.eu
- 39. 4. Data preparation in IUCLID CHALLENGES ACROSS INDUSTRIES • Large volume of product needs submission/ Large volume of data set to be prepared for complex objects • Different formats / Different internal data set of the data required • Low trustworthiness of data received from suppliers • Skipping packaging and manuals • A lot of administrative work • High manual efforts • Crashing of ECHA cloud service due to distance and internet connection • High error rate, slow
- 40. 5. Data submission & maintenance CHALLENGES ACROSS INDUSTRIES • Data confidentiality and its disclosure • Product update • Supplier change • SVHC update (substances considered to be added are not always added on the list) • Incomplete data • Keeping data updated and maintained
- 41. How 1cc supports companies with managing their SCIP obligation • Identification of a company’s distribution model and identification of roles and responsibilities of legal entities • Support on SCIP registration of legal entities and users • Evaluation of product scope with regards to SCIP • Expertise and support in identifying articles including SVHC calculation, with a special focus on borderline cases • Identification and selection of exemplary products for initial creating and upload of dossiers into SCIP database & operational support • Guideline and explanation of the grouping, referencing and simplified SCIP notification options • Consultancy on demand
- 42. © Assent Compliance 2021 43 Automated Data Collection & Submission to ECHA SCIP Database. 6
- 43. © Assent Compliance 2021 © Assent Compliance 2021 44
- 44. © Assent Compliance 2021 © Assent Compliance 2021
- 45. © Assent Compliance 2021 Automated Data Collection & Submission (i) SCIP Stages of Grief: Understanding Companies’ Compliance Approaches Phase 1: Denial Phase 2: Panic Phase 3: Structure Phase 4: Automation Multiple customers still deny having to actually act. Quick and dirty implementations until a certain deadline… (often January 5). Process optimization.
- 46. © Assent Compliance 2021 Automated Data Collection & Submission (ii) Companies Stuck in the Structure and Automation Phase Many companies have powered through the panic phase to achieve quick and dirty solutions. Examples of initial “interim” solution challenges: ▸ Resource-intensive and high manual workload. ▸ Cost inefficiency. ▸ Future change management not considered. ▸ Supplier outreach not optimal. ▸ Inefficient communication of SCIP data to customers. ▸ Not all duty holders have been identified or set up correctly. ▸ Actually compliant? Structure & Automation Copyright © by Sidney Harris.
- 47. © Assent Compliance 2021 Copyright © by Sidney Harris. Automated Data Collection & Submission (iii) Companies in “Structure” and “Automation” Phase But also companies may want to take their SCIP program from basic regulatory compliance to competitive advantage: ▸ Consider what benefits the company can achieve by creating a best-in- class SCIP solution. ▸ Consider the competition. ▸ Consider how the company’s suppliers can be supported: ▹ Use Assent supplier educational materials, Supplier Portal, etc. ▹ Use Assent as an EU representative. Structure & Automation
- 48. © Assent Compliance 2021 © Assent Compliance 2021 Automated Data Collection & Submission (v) Dossier Management Substances of Concern Detection Supplier Training SCIP Data Collection SCIP Data Review Transmission SCIP Dossier Creation Program Scoping ▪ Monitor Suppliers for updates ▫ Chemical composition ▫ Alternative substances/parts ▫ Continued market access ▪ Product scope ▪ Duty holder evaluation ▪ Full material declarations (FMDs) ▪ Test reports ▪ Supplier surveys ▪ Supplier declarations of compliance (DoCs) ▪ Education ▪ Q&A ▪ Webinars ▪ Learning management system ▪ Email requests ▪ Accessing databases ▪ Phone calls ▪ Form for collection ▪ Multilingual support ▪ Aggregate supplier SCIP declarations ▪ Completion of any internal SCIP data points ▪ Article mapping ▪ Duty holder determination ▪ Data validation ▪ Due diligence ▪ Data reconciliation ▪ Supplier corrective actions, if needed ▪ Monitor ECHA for updates ▫ Candidate SVHCs ▫ Restrictions ▫ Authorizations ▫ Enforcement ▪ Update SCIP dossier article record ▫ Part number changes ▫ Article category ▫ Taric codes ▫ Safe handling instruction ▪ Update SCIP dossier substance record ▫ Minimum twice per year ▫ Material category ▫ European Product Categorisation System (EuPCS) ▪ System-to-system ▪ IUCLID website ▪ SCIP customer declarations ▪ Duty Holder Mapping ▪ IUCLID Export
- 49. 51 SCIP – Choose the best approach 7
- 50. Enforcement ▪ In case of continuous infringement, a penalty of €100–€1,000 per day of infringement. ▪ On conviction or indictment, a fine of up to €80,000 or imprisonment not exceeding two years, or both. ▪ On second/subsequent conviction, a fine of up to €80,000 or imprisonment not exceeding four years, or both. ▪ Where applicable, products will be removed from the marketplace. ▪ July 2020 — EU WFD transposed into member states national law. ▪ Currently, every EU member state enforcement authority differs on the level of inspection and enforcement of non- compliant products. ▪ However, EU 2019/1020 signals a harmonization of inspection and enforcement across the EU. Manufacturer Source: https://echa.europa.eu/documents/10162/24205171/wfd_database_presentation_en.pdf/ EU REACH — New Devices EU WFD — End of Life EU Market Surveillance — All Products
- 51. 53 SCIP – Choose the best approach Manual data collection & Submission Automated data collection & Submission
- 52. Q&A ▪ info@assentcompliance.com ▪ contact@1cc-consulting.com Any additional questions can be sent to: