SCIP – “choose the best approach”

SCIP – “choose the best
approach”
Presented at: Future Bridge Conference, September 2021.

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

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
Background on SCIP
Reporting Obligations
1

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
• 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.”
Understanding the Reporting Obligations

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.

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.

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
The SCIP timeline so far
Source: echa.europa.eu

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

Storage
Data Submission
Manual Preparation Online
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

• 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.
• 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

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.
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

Source: ECHA SCIP IT User Group July 15, 2020
Complex Article
Dataset
Assembly Level Article
Record(s)
Lower-Level Article
Record(s)
Lower-Level Article
Record(s)

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

▪ 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
Waste Operators Authorities
Competitors, Consumers & Other
Interested Parties

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
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
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).
What can be searched for

22
Clicking onto the details screen will open up a factsheet view with detailed data
Factsheet View (Simple Article)

23
Factsheet View (Complex Article)

24
EU REACH Reporting
vs.
ECHA SCIP Reporting
3

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)

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
SCIP Database State of Play
4

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.
Extracted From SCIP IT User Group Meeting on March 25, 2021

29
Methods of Data Transmission
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
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.
Extracted From SCIP IT User Group Meeting on March 25, 2021

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.
Most reported substances
• Lead,
• Lead monoxide,
• Diboron trioxide,
• 4,4'-isopropylidenediphenol,
• Lead titanium trioxide.

Manual Data Collection & Submission to
ECHA SCIP Database
5

34
1cc guides you through the jungle of regulatory
requirements worldwide

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

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

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

2. Understand your scoped product
• Identifying out of scope products
• Understanding of an article definition
• “Once an article, always an article”

3. Supply chain communication
• 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

4. Data preparation in IUCLID
• 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

5. Data submission & maintenance
• 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

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

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.

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.

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

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

51
SCIP – Choose the best
approach
7

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
EU REACH — New Devices
EU WFD — End of Life
EU Market Surveillance — All
Products

53
SCIP – Choose the best approach
Manual data collection & Submission
Automated data collection & Submission

Q&A
▪ info@assentcompliance.com
▪ contact@1cc-consulting.com
Any additional questions can be sent to:

SCIP – “choose the best approach”

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