THE REACH

HANDBOOK
YOUR GUIDE TO SVHC COMPLIANCE
TABLE OF CONTENTS

INTRODUCTION........................................................................................... 1
CHAPTER 1
REACH FUNDAMENTALS............................................................................................................................................ 3
EU REACH................................................................................................................................................................... 3

CHAPTER 2
UNDERSTANDING ARTICLES & SVHC COMPLIANCE..................................................................................... 8
What Constitutes an Article Under REACH?.......................................................................................................... 9
SVHCs & Notification Requirements...................................................................................................................... 9
Guidance on Requirements for Substances in Articles.................................................................................... 10

CHAPTER 3
MANAGING RISK & AVOIDING ENFORCEMENT ACTION............................................................................ 12
Case Study: Customer Stops Shipment Due to REACH SVHC......................................................................... 14

CHAPTER 4
MEETING YOUR REACH REQUIREMENTS......................................................................................................... 18
Collecting Substance Data From Your Supply Chain........................................................................................ 19
Communication With Suppliers.............................................................................................................................20
Managing Substances on the Candidate List.....................................................................................................21
Responding to Expiring Authorizations................................................................................................................22

CHAPTER 5
REACH COMPLIANCE ESSENTIALS......................................................................................................................24

ABOUT ASSENT
Who Is Assent? ........................................................................................................................................................26
What We Do .............................................................................................................................................................26
Some of the Industries We Work With ................................................................................................................27
The Assent Compliance Platform ........................................................................................................................28
Our Global Offices ...................................................................................................................................................29
INTRODUCTION
The Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation (EC 1907/2006)
has grown exponentially in scope and impact over the last decade. Today it is clear to many forward-thinking
companies that successful REACH compliance requires the abandonment of inefficient and disorganized
“Old World” compliance methods. These outdated approaches must be replaced by a commitment to
more structured and comprehensive forms of data collection. In contrast, “New World” approaches help
ensure companies avoid the financial, legal, operational, and other risks associated with non-compliance.

Implemented with the goal of protecting people and the environment from potentially harmful chemical
substances, the REACH Regulation makes industry responsible for managing the risks of these substances
in the market, and for providing the relevant safety information to users and consumers. It also prioritizes
the progressive phase-out of some of the most dangerous chemicals in products once suitable alternatives
are found.

This eBook serves as the go-to resource for compliance personnel navigating the REACH Regulation’s
increasing complexity. It is a useful tool for those seeking to modernize their REACH compliance programs
to ensure continued market competitiveness and supply chain protection.

In this eBook, you will learn:

§ The fundamentals of the REACH Regulation as it pertains to finished objects and products.
§ Important dates and deadlines for compliance.
§ How to mitigate risk and avoid negative enforcement action.
§ Why automated supply chain data management should matter to your company.

THE REACH Handbook: Your Guide to SVHC Compliance

1
01
CHAPTER

REACH
FUNDAMENTALS
CHAPTER 1:
REACH FUNDAMENTALS
EU REACH
The European Union (EU)’s REACH Regulation was released in 2006 and entered into force on June 1, 2007. The
regulation impacts almost every product made in or imported into the European Economic Area (EEA).1 It has been
described as the most complex piece of legislation in the history of the EU. Given that REACH applies to individual
chemical substances as well as substances contained within objects (termed “articles” under the regulation), the
regulation affects the use and sale of a vast array of items, ranging from industrial goods to cleaning products,
clothing, furniture, and appliances.

The REACH Regulation requires all companies manufacturing or importing chemical substances into the EEA in
quantities greater than one metric ton per year to register these chemicals with the European Chemicals Agency
(ECHA) in Helsinki, Finland. In doing so, they must be able to prove to the ECHA the chemicals can be used safely.
The agency assesses these individual registrations for compliance and ultimately determines whether the risks
posed by the substances can be adequately managed. If a risk is deemed unmanageable, authorities may ban it
from being placed on the market, restrict the use of the substance, or make it subject to a prior authorization.

1
The European Economic Area (EEA) includes all European Union member states, in addition to Iceland, Liechtenstein, Norway, and Croatia.

THE REACH Handbook: Your Guide to SVHC Compliance

3
 WHO IS REQUIRED TO REGISTER?
è EU manufacturers or importers of substances on their own or in mixtures.
è EU producers or importers of articles meeting the criteria in the Guidance on
Requirements for Substances in Articles.
è An EU “only representative” appointed by a manufacturer, formulator, or article
producer that is outside the EU to fulfill the registration needs of importers.

THE FOUR PROCESSES OF REACH: REGISTRATION, EVALUATION, AUTHORISATION, & RESTRICTION

REGISTRATION
When companies manufacture or import chemical
substances in quantities greater than one metric
ton per year, they must collect information about the
properties within these substances and assess the
risks they pose. If the substance has not already been
registered, this information must be communicated
to the ECHA using a registration dossier. Companies
manufacturing or importing the same substance must
work together to submit a joint registration, as the
ECHA requires only one registration per substance.
Registration is required for individual substances,
substances in mixtures, and certain substances in
articles. Articles containing a substance or mixture
that is intentionally released from the product during
normal and foreseeable use must be registered when
the amount of the substance imported for this purpose
exceeds one metric ton per year. In this case, “normal
and foreseeable use” does not pertain to the main
function of the product. For instance, some toys may
release a scent, but it is not required for the toy to
perform its main function. If the intended release was
already included as a use in the original substance
registration, further registration is not required.
EVALUATION
The ECHA and EU member states are responsible for
evaluating the information submitted by companies
to the registration dossier. Their evaluations focus on
three areas:
§ Assessing the quality of testing proposals
submitted by registrants.
§ Checking the dossiers submitted by registrants
for compliance with the REACH Regulation.
§ Clarifying whether a substance poses a risk to
human or environmental health.
During substance evaluations, the member states may
request further information from the registrants about
a substance if concerns are raised regarding its safety.
If a substance is deemed unsafe, risk management
measures may be implemented, including restrictions,
the identification of Substances of Very High Concern
(SVHCs), or other actions outside the scope of the
REACH Regulation.
In fulfilling its duties under Article 54 of the REACH
Regulation, the ECHA must publish a report each
February detailing the progress it made on its
evaluation obligations throughout the previous year.
This report includes recommendations for future
registrants to improve their submissions.

4 THE REACH Handbook: Your Guide to SVHC Compliance

AUTHORISATION
The significance of the authorization process is to
ensure that risks posed by SVHCs currently in use
are properly managed, while simultaneously ensuring
these substances are progressively replaced by
safer alternatives. This element of the regulation is
governed by a two-step regulatory process involving
the Candidate List and the Authorisation List.
The Candidate List: SVHCs on this list have been
identified by European member states and/
or the ECHA as being a risk to human and/or
environmental health. Once identified, they are added
to the Candidate List and entail legal obligations
for companies manufacturing, importing, or using
these substances (as stand-alone substances, in
mixtures or in articles). Candidate List SVHCs may
then be labeled as candidates for inclusion in the
Authorisation List (Annex XIV).
The Authorisation List: Substances are added to the
Authorisation List from the Candidate List according
MAKING AN APPLICATION FOR AUTHORIZATION
Manufacturers, importers, and downstream users can
apply for specific authorizations to place a substance
featured on the Authorisation List on the market, or to use
it in production. An application must include, at minimum,
a chemical safety report, an evaluation of any available
alternatives to that substance, and a plan detailing how
the entity proposes to replace the substance in time if
suitable alternatives are available.
Authorizations are granted if the applicant demonstrates
that the hazards of using the SVHC can be mitigated
adequately. Authorizations can also be granted if a
socioeconomic analysis reveals the benefits of using the
substances outweigh the risks, and that there are no viable
alternatives for the substance.
THE REACH Handbook: Your Guide to SVHC Compliance
to the order in which the ECHA prioritizes them. Priority
is generally given to substances that are categorized
as persistent, bioaccumulative, and toxic (PBT) or very
persistent and very bioaccumulative (vPvB), or that are
in high volume market distributio
Once on the Authorisation List, a substance
cannot legally be placed on the EU market or
used after its sunset date, unless a manufacturer,
importer, or downstream user is granted a specific
authorization for that use, or if the use is exempted
from authorization, as per Annex IV of the REACH
Regulation. An important exception to this rule is
when a company has applied for an authorization, but
has not yet received a decision. In such cases, the
company can continue supplying the product while
the decision is pending (even if the sunset date has
passed). If the application is refused, the substance
must be withdrawn from the market immediately. All
applications for authorizations must be made at least
18 months prior to the substance’s sunset date.
Once the application fee is received from the company, the
ECHA’s Risk Assessment Committee and the Committee
for Socio-Economic Analysis prepare draft opinions on
the matter, and eventually publish their final decision
through the European Commission. Where authorizations
are granted, companies must comply with the specific
requirements of that decision (including labeling needs).
Downstream users of an authorized substance also
have a responsibility to comply with the decision. This
means decisions about the Authorisation List inherently
affect a range of supply chain actors involved in the
production and sale of substances and articles in the EU
market. This makes strong supply chain communication
a compliance imperative for companies in scope of the
REACH Regulation.
5
 RESTRICTION
Restrictions are used when the risks to environmental
and human health from any given substance are
deemed unacceptable, and involves limits or bans on
the manufacture, sale, or use of that substance. This
can apply to individual substances or those in mixtures
and articles. Member states and the ECHA can
propose such restrictions, and anyone can comment
on proposals in favor of particular restrictions
(including interested companies, industry bodies, and
civil society). Final decisions on restrictions are made
by the ECHA, member states, and relevant experts.

Once a final restriction has been decided, all

manufacturers, importers, distributors, and
downstream users, including retailers, must comply.
It is up to the authorities in each member state to
govern enforcement.

6
02
CHAPTER

UNDERSTANDING
ARTICLES & SVHC
COMPLIANCE
 CHAPTER 2:
UNDERSTANDING
ARTICLES & SVHC
COMPLIANCE
The REACH Regulation is one of the most complex regulations in EU history, incorporating a number of
obligations that require complex processes in order to comply. Staying up to date with the regulation
and having those processes in place are essential to ensuring your compliance program does not
fall behind and expose your company to the significant risks associated with non-compliance.

Key to complying with the REACH Regulation is understanding how it defines an article, and how
that definition molds the way companies structure their compliance programs.

8 THE REACH Handbook: Your Guide to SVHC Compliance

WHAT CONSTITUTES AN ARTICLE UNDER THE REACH REGULATION?
Prior to a 2015 ruling of the Court of Justice of the
European Union (CJEU) that clarified the issue,
a common interpretation of the rule was that an
imported complex article comprised of multiple parts
was considered a single article and therefore treated
as such for the purpose of determining whether it
contained SVHCs above the allowed threshold.
However, in its landmark ruling (known as “Once an
Article, Always an Article”), the CJEU said the SVHC
threshold and notification requirements should
apply to individual articles within a complex product.
This ruling drastically changed the way companies
apply the REACH Regulation to their products, as it
requires importers to determine whether any article
within their product contains an SVHC over the 0.1
percent weight by weight (w/w) threshold. If so, the
importer (along with each subsequent purchaser
of that product or component) has supply chain
communication requirements.

SVHCS & NOTIFICATION REQUIREMENTS

The REACH Regulation requires any supplier of articles
This information should be given to the recipient of
containing SVHCs to provide the recipient of the article
the article when it is supplied for the first time after
(Article 33[1]) or the consumer (Article 33[2]) with the
being added to the Candidate List. Should a consumer
necessary safety information about that article when
request information about substances over threshold,
the following two conditions are met:
including safety information, it must be given within
§ The substance is included in the Candidate List. 45 days after the request is received, free of charge.
§ The substance is present in articles produced
and/or imported above the 0.1 percent
w/w threshold.

Learn More
For more detailed information on what is considered an article under the
REACH Regulation, download the whitepaper REACH: Applying the New
Article Interpretation.

Download Whitepaper

9
 GUIDANCE ON REQUIREMENTS FOR SUBSTANCES IN ARTICLES
In June 2017, the ECHA released an update to their This documentation should include:
Guidance on Requirements for Substances in Articles 2
§ Information requests made to suppliers of
in response to the CJEU’s 2015 “Once an Article,
substances, mixtures, or articles.
Always an Article” ruling. The much-anticipated
revision provided industry and national enforcement § Information received from suppliers, including
bodies with further clarification on the communication certificates and other records.
requirements associated with SVHCs, particularly in § Decision-making on whether certain objects are
relation to complex products. articles, substances, or mixtures.

With this release, suppliers and importers have the § Determination on whether specific
context they need to better assess compliance with requirements apply to the objects, based on
the requirements of Article 33 and Article 7(2) of the information received (among other factors).
REACH Regulation. Most importantly, the guidance This update from the ECHA solidifies the importance
offers a comprehensive set of examples to help of efficient supply chain engagement, while also
companies understand the conditions under which reinforcing the need for a REACH compliance program
they must communicate the composition of their capable of scaling with the expanding REACH
products. Companies that manufacture complex regulatory environment. Companies can achieve
products now have a more specific mandate to gather this by leveraging material declaration standards
information from the supply chain and document such as IPC-1752A, IPC-1754, and IEC 62474 in
the process — especially given the guidance clearly their compliance programs. More information on
states “producers and importers are strongly implementing standards and developing a strong
recommended to document the results of their REACH program is presented in Chapter 4: Meeting
compliance assessment.” Your REACH Requirements.

2
European Chemicals Agency. (2017). Guidance on Requirements for Substances in Articles. Retrieved from https://echa.europa.eu/guidance-documents/
guidance-on-reach?panel=guidance-on-requirements-for-substances-in-articles#guidance-on-requirements-for-substances-in-articles

10 THE REACH Handbook: Your Guide to SVHC Compliance

03
CHAPTER

MANAGING
RISK & AVOIDING
ENFORCEMENT
ACTION
 CHAPTER 3: MANAGING
RISK & AVOIDING
ENFORCEMENT ACTION
The Guidance on Requirements for Substances that fail to overcome these challenges face major
in Articles will act as a catalyst for enforcement.
3
setbacks, some of which are explained below.
The CJEU’s ruling gave companies time to make
1/ Supply Chain Interruption
adjustments to their programs in order to meet new
Companies and suppliers that do not meet REACH
requirements created by the ruling. As companies
Regulation requirements could subsequently fail
made this adjustment, enforcement was relatively lax.
to meet the demands of their purchasing orders.
However, the guidance provides a clear picture of what
This has a direct and immediate impact on revenue,
enforcement bodies expect to see in terms of REACH
and a longer-term impact on customer satisfaction
compliance, meaning companies must take notice
and confidence.
and meet those expectations, or face enforcement
activities and other risks. The same is true in cases where companies do
comply with the REACH Regulation, meaning they
Even with the guidance at hand, the intricacies and
may cease production of a certain material or product.
changing nature of the regulation create significant
challenges for REACH compliance. Companies

3
European Chemicals Agency. (2017). Guidance on Requirements for Substances in Articles. Retrieved from https://echa.europa.eu/guidance-documents/
guidance-on-reach?panel=guidance-on-requirements-for-substances-in-articles#guidance-on-requirements-for-substances-in-articles

12 THE REACH Handbook: Your Guide to SVHC Compliance

2/ Direct Enforcement Action
REACH enforcement actions against non-compliant
companies are laborious at best and prohibitively
disruptive at worst, even to the extent of forcing
business closure or the cessation of production.
Enforcement actions can also involve financial
penalties and the painful implementation of new
auditing procedures dictated by authorities (for
example, forced implementation of a detailed
compliance plan, the hire of a dedicated compliance
officer, ongoing inspections and cumbersome audits
on a periodic basis).
The EU has committed to making enforcement of
regulations such as REACH a priority. As a result,
companies can expect enforcement cases to rise.
3/ Compromised Worker Health & Safety
In particularly egregious cases where, for example,
SVHCs pose a significant threat to the safety of workers
through inhalation and dermal contact, those at the
head of non-compliant companies may face criminal
prosecution, including the risk of jail time and associated
fines. These same risks can also apply to the import, sale
or use of SVHCs that pose environmental risks.
Companies that do not take into account the extent
of REACH-related risks will struggle to maintain
continued market access in the face of this evolving
regulation. The following real-life case study highlights
a number of these risks, helping compliance personnel
4
think about the blind spots in their own REACH
compliance program.

4
Council of the EU. (2018). EU moves to keep unsafe products off the market: Council agrees position on enhanced enforcement and compliance rules. Retrieved from https://
www.consilium.europa.eu/en/press/press-releases/2018/11/23/eu-moves-to-keep-unsafe-products-off-the-market-council-agrees-position-on-enhanced-enforcement-and-
compliance-rules/pdf

RECENT ENFORCEMENT ACTION

On November 6, 2019, the ECHA released a report
detailing the results of an enforcement pilot project
conducted between October 2017 and December 2018.5
The project was conducted in 15 participating countries
with inspections of 682 articles from over 405 companies.
The products chosen for inspection belonged to product
categories with a high likelihood of containing SVHCs. These
categories included clothing, footwear, home textiles, wires,
cables, electronic accessories, plastic or textile flooring, wall
coverings, and other plastic and rubber products.
Of the 682 articles tested, 84 (12 percent) were found to
contain SVHCs in concentrations above the 0.1 percent w/w
threshold. Most suppliers of these products (88 percent)
failed to communicate sufficient information about SVHCs
5
European Chemicals Agency. (2019). FORUM Substances in Articles Pilot Project. Retrieved from https://echa.europa.eu/documents/10162/13577/
sia_pilot_project_report_en.pdf/f9fc153b-a322-43be-1ba1-44f4e5cb02c8
6
European Chemicals Agency. (2020). Inspectors to check products sold online that contain harmful substances. Retrieved from https://echa.europa.eu/-/
inspectors-to-check-products-sold-online-that-contain-harmful-substances
to the appropriate stakeholders in the supply chain. Of
companies selling directly to consumers, 51 percent were
found to have supplied insufficient information about SVHCs
to fulfill their obligations to inform consumers upon request.
The ECHA continues to coordinate enforcement projects
designed to harmonize enforcement among member states,
and verify and improve the level of compliance with regard
to specific obligations under several regulations, including
REACH. Projects that explore REACH compliance and
enforcement are known as REACH-EN-FORCE (REF). The
eighth such project concentrates on harmful substances
contained in products that are purchased online in 29
participating countries.6 The operational phase is scheduled
to conclude on December 31, 2020, with a formal report to
follow in 2021.

THE REACH Handbook: Your Guide to SVHC Compliance

13
 CUSTOMER STOPS
SHIPMENT DUE TO
REACH SVHC
MULTI-MILLION DOLLAR CONTRACT VOID
AFTER SVHCS DISCOVERED IN PRODUCT
REGULATION
The Registration, Evaluation, Authorisation and Restriction
of Chemicals (REACH) Regulation, SVHCs.

STORY
Note: The identities of the companies involved in this real
case have been changed to maintain anonymity.

Accessor was a company involved in the production of

protective covers and other accessories for a high-volume
tablet and mobile device manufacturer, known as HVT Pro.
STUDY

Accessor won the contract in November to produce 3

million polyurethane covers of various colors for HVT
Pro’s tablets. Accessor had a very tight deadline, as the
CASE

covers needed to be produced in sufficient volumes to

align with the launch of HVT Pro’s new tablet range in
March the following year.

Within the contract, HVT Pro included a clause in their

purchasing terms and conditions that would allow the
company to reject the supply of covers if it contained
more than 0.1 percent w/w of any SVHCs prohibited
under the REACH Regulation.7

To meet their aggressive timeline, Accessor purchased

their stock of polyurethane as soon as they won the
contract with HVT Pro. At that time, the polyurethane
7
The European Chemicals Agency. (2016). Candidate List of substances of very high

14
concern for Authorisation. Retrieved from https://echa.europa.eu/candidate-list-table
supplier was able to demonstrate the materials
did not contain any SVHCs over the 0.1 percent
w/w threshold. Using this stock of polyurethane,
Accessor produced all the covers within the
allotted time and completed their first delivery to
HVT Pro’s distribution warehouse in early January.
As a way to enforce the company’s contract
requirements, HVT Pro maintains an internal
control program that analytically tests the
contents of every item shipped to their
warehouse for evidence of SVHCs and other
materials. This allows HVT Pro to demonstrate
compliance with the REACH Regulation prior
to the distribution of their products. After
performing the test on Accessor’s tablet covers,
HVT Pro found that the polyurethane material
used in the covers contained 17 percent w/w of
dimethylformamide.
Dimethylformamide was added to the SVHC list
a month after Accessor purchased their supply
of polyurethane. Accessor did not request
information on dimethylformamide from their
supplier because it was not an SVHC at the time
the materials were purchased.
ENFORCEMENT OUTCOME
It was determined that Accessor was in breach of
its contract with HVT Pro. As part of the contract,
HVT Pro had all of the covers collected from their
warehouse at Accessor’s expense. Fortunately
for HVT Pro, the company had another viable
supplier for the covers that would be able to meet
the demands of the March tablet launch.
Unfortunately for Accessor, the covers were
designed specifically for HVT’s tablets and there
was no other secondary market for them to sell
to. They were subsequently forced to destroy the
tablet covers.
The total cost of production, logistics and waste
management for the three million tablet covers
totaled $7 million USD. This cost does not
account for potential revenue losses due to lack
of customer confidence, credibility, and other
perceived risks surrounding the Accessor brand.
LESSONS LEARNED
The first point of risk for Accessor was their
failure to understand the possible impact of their
obligations to their client. There is a significant
difference between being compliant with the
REACH Regulation’s communication requirement
(Article 33) regarding SVHCs above 0.1 percent
8
w/w, and a customer’s requirement that a product
not contain any SVHCs above 0.1 percent w/w.
If Accessor had been equipped with better
regulatory knowledge, they may have identified
this difference and negotiated for the use of
different language in the contract.
The second point of risk for Accessor was that
the SVHC list has consistently grown, based on
precedent, every six months. Some companies
have adopted a program requiring suppliers
to provide full material disclosures (FMDs)
for all materials used in their products. Having
this information at hand may have prevented
the issue, or could have allowed Accessor
sufficient time to source alternate materials
for their covers, enabling them to fulfil their
contractual obligations.
8
Immediately after a substance is included on the Candidate List of SVHCs, suppliers of articles that contain such substances at a concentration above 0.1
percent w/w must provide enough information to allow for the safe use of the article by the recipient.
9
For more on full material disclosures, see http://www.assentcompliance.com/fmd-complete/.
CONSEQUENCES
§ $7 million loss in revenue
§ Lost multi-million dollar contract
§ Damage to brand credibility
As demonstrated in this case study, failing to
comply with regulatory, customer, and other
requirements under the REACH Regulation can
result in millions of dollars in lost revenue or
penalties, the loss of investment opportunities
and contracts, and reputational brand damage.
In certain cases, non-compliance leads to a chain
reaction of negative impacts to the business,
which companies struggle to overcome.
The best way to minimize these issues altogether
is to ensure compliance through education,
access to internal or external subject matter
9
experts, strong data collection and management
mechanisms, and the establishment and
maintenance of a proactive, informed due
diligence program.
04
CHAPTER

MEETING
YOUR REACH
REQUIREMENTS
 CHAPTER 4:
MEETING YOUR
REACH REQUIREMENTS
As a regulation in a constant state of evolution, REACH compliance is no small undertaking and requires an incredibly
robust due diligence program. In this high-pressure environment, compliant companies know where their products
come from and which substances are present in each article they purchase.

With firm guidance from the ECHA on the expectations for companies in scope of the REACH Regulation, the onus
falls upon individual companies to meet these expectations using a comprehensive compliance program backed
by regulatory foresight, effective supply chain communication and, above all, strong data. These functions are the
key differentiating factors between the more time and resource intensive “Old World” REACH compliance programs
of the past, and the kinds of streamlined REACH compliance systems that will keep your company ahead of this
regulation in the future.

18 THE REACH Handbook: Your Guide to SVHC Compliance

COLLECTING SUBSTANCE DATA FROM YOUR SUPPLY CHAIN
“OLD WORLD” APPROACH
§ Manual mass email campaigns to suppliers
to request substance information.
§ Unstructured data in responses, requiring
time-intensive organization.
§ Manual data processing and compilation.
§ Potential for liabilities in the medium to long
term as regulatory demands intensify.
“NEW WORLD” APPROACH
§ Automated data collection sendouts triggered
by structured workflows.
§ Data governance and structure embedded
within supplier data collection method.
§ Automated data intake through dedicated
supplier portal.
§ Scalable solution results in reduced liability
for the future.
Data collection from the supply chain is integral to
successful REACH compliance. An example of this is
Article 33 of the regulation, which requires companies
to communicate sufficient substance information
down the supply chain to customers where those
substances exist in quantities above the 0.1 percent
w/w threshold. In all cases, this will require the use
of organized data collection methods, including
email campaigns, which should be underpinned
by strong supplier relationships rooted in trust and
receptive feedback loops. The level of effort required
THE REACH Handbook: Your Guide to SVHC Compliance
by companies to obtain the necessary information
depends on the supply chain communication systems
and tools in place.
In the past, companies in scope of the REACH
Regulation met their compliance obligations using
manual mass email campaigns to supply chain
actors to request substance information. In addition
to being time-intensive, this resulted in companies
receiving a wave of unstructured information and
then being required to manually organize this data to
demonstrate REACH compliance. The potential for
error and oversight in this high touchpoint approach
is significant.
As supply chains become more global in nature,
barriers to data collection are on the rise. These
include more complex supply chain links, larger
supplier pools, and even linguistic and time zone
differences, which can impact a company’s ability to
obtain timely product information from the suppliers
in their network. With big money, big contracts, and
big market access at stake, “Old World” approaches
to REACH compliance no longer suffice. Today,
companies in scope need the ability to automatically
collect accurate substance information from their
supply chains in response to an evolving REACH
regulatory landscape. For global supply chains in
particular, this makes automated data collection,
multilingual communication, and structured and
searchable data inventories essential.
19
 COMMUNICATION WITH SUPPLIERS
“OLD WORLD” APPROACH
§ Supplier lists compiled and updated manually
over time.
§ Suppliers manually email declarations to
a point of contact.
§ Time delays on receipt of supplier information
due to manual processing methods.
§ Suppliers left to educate themselves about
compliance requirements.
“NEW WORLD” APPROACH
§ Dedicated supplier portal for data submission.
§ Multilingual support for suppliers
making declarations.
§ Real-time supplier feedback and scoring.
§ Supplier education programs to ensure
accurate and informed declarations.
Effective and timely communication with all actors
in the supply chain is the basis of a high-functioning
REACH solution. In terms of suppliers, strong lines of
20 THE REACH Handbook: Your Guide to SVHC Compliance
communication ensure your company has access to
essential substance and product information at all
times to demonstrate regulatory compliance.
Unfortunately, suppliers don’t always have the same
operational capacity as their customers, at times
making it difficult for them to respond to requests for
information. In particular, they often lack the resources
to process the high volume of requests they receive, an
understanding of what is being asked of them and why,
and the support and technology to respond effectively.
This can result in compromised or inaccurate data and
high levels of supplier unresponsiveness.
Successful REACH programs are those that recognize
these challenges and take firm steps to better support
their supplier networks. This is achieved through
dedicated communication pathways for suppliers,
the provision of requests in their dominant language,
on-demand feedback and advice, and a commitment
to training and education to help suppliers understand
the expectations placed upon them in pursuit of
REACH compliance.
MANAGING SUBSTANCES ON THE CANDIDATE LIST
“OLD WORLD” APPROACH
§ Reactive collection of substance data in
response to regulatory changes.
§ Static data collection capabilities.
§ Manual update of substance data from supply
chain.
§ Manual organization of email requests to
suppliers for data.
“NEW WORLD” APPROACH
§ Proactive collection of supply chain data
ready for regulatory shifts.
§ Configurable data collection.
§ Instant access to substance data,
updated automatically.
§ One-click survey sendouts and
campaign creation.
REACH is an evolving regulation, with new substances
historically being added to the Candidate List every
six months. It is therefore essential for companies
to be able to take immediate and concrete action if a
substance they use makes its way onto the list. To do
so, compliance personnel need the right information
on hand so they can make informed decisions in
response to these rapid changes.
In the past, this was achieved using manual data
collection, which can take six or more months to
simply find out if an SVHC is in your supply chain. The
timeline expands further to accommodate the lengthy
process of tracking where else the SVHC is found in
the chain, testing your product and mapping out an
appropriate course of action, ranging from altering
the product, locating new suppliers, or removing
the product and its inventory from your supply
chain altogether.
Today, however, robust REACH compliance
programs are nimble by nature, having the capacity
to automatically update workflows in response
to changes in the Candidate List, launch survey
campaigns at a moment’s notice, and even alert
you instantly if you have any listed SVHCs in your
supply chain.
Full material disclosures are a strong example of
these kinds of proactive supply chain data collection
methods in action. As the name implies, FMDs provide
companies with a full breakdown of the composition
of their products, down to the homogeneous level.
Often utilized for REACH compliance programming,
they show companies which substances are in
which products, in what concentration and whether
they exceed the relevant regulatory threshold. While
traditional material declarations only list the presence
of restricted and declarable substances, FMDs provide
a full breakdown of the entire composition of any given
product. By requiring less time and fewer touchpoints,
these kinds of sophisticated supply chain data
management solutions give you maximum notice and
supporting data to help you comply with the REACH
Regulation as efficiently as possible.
Learn More
Learn how to simplify your
REACH program with FMDs.
Get your copy of the eBook
Full Material Disclosures:
Building Resilience With
Data to learn more.
Download eBook
 RESPONDING TO EXPIRING AUTHORIZATIONS
“OLD WORLD” APPROACH should not be a stressful or last-minute process if your
§ Untraceable data requests. due diligence program is appropriate.

§ Minimal oversight, many touchpoints. The best compliance programs are those capable
§ Rigid due diligence program lacking capacity of identifying which suppliers use the SVHC, and are
for regulatory adaptation. able to: (a) communicate this change or an associated
deadline with those suppliers, (b) automatically scan
§ Time-intensive supply chain data
the supply chain to check if any new products contain
collection methods.
this substance, and (c) work in tandem with engineers
“NEW WORLD” APPROACH and product specialists to ensure the requisite changes
§ Traceable and auditable supply chain are implemented in advance of key cut-off dates.
surveying activities. These kinds of programs can ensure companies
§ Broad oversight of supply chain activities, fewer stay ahead of regulatory changes, including expiring
touchpoints. authorizations and the addition of new substances
§ Agile due diligence program to support ongoing to the Candidate List, at all times. In doing so, they
compliance. help companies be proactive about their due diligence
actions rather than rely on the reactive methods
§ Instantaneous mass surveying of supply chain
that characterize “Old World” REACH compliance.
for real-time substance information.
Being prepared for regulatory changes and new
If your company has received an authorization for the requirements starts with comprehensive supply
use of a particular substance, it will have also received chain communication and a commitment to early
an expiry date for that authorization. When faced action. Again, this all comes back to data and the
with these deadlines, companies can either apply need for agile, traceable, and automated supply chain
for a renewal of their authorization, find an alternate communication and reporting.
substance, or discontinue the product. However, this

DON’T LET WHAT YOU DON’T KNOW DAMAGE

YOUR COMPANY’S BOTTOM LINE
The first application for authorization was given to UK company Rolls-Royce in 2014 for bis(2-ethylhexyl) phthalate
(DEHP).10 The company used the substance in the manufacture of aircraft engine fan blades. What makes this case
particularly interesting is that the substance was being used by a supplier, and not directly by the company itself. This
demonstrates the importance of knowing exactly which substances are in your supply chain, from start to finish.

10
European Chemicals Agency. (2014, January 3). Authorisation to use a substance of very high concern — first opinions adopted. Retrieved from https://echa.europa.eu/
view-article/-/journal_content/title/authorisation-to-use-a-substance-of-very-high-concern-first-opinions-adopted

22 THE REACH Handbook: Your Guide to SVHC Compliance

05
CHAPTER

REACH
COMPLIANCE
ESSENTIALS
 CHAPTER 5: REACH
COMPLIANCE ESSENTIALS
The REACH Regulation is becoming increasingly complex, requiring more sophisticated due diligence and
data collection approaches from companies seeking to stay compliant. While there were only a handful of
SVHCs and associated restrictions for companies to deal with at the onset of the regulation, this number is
now in the hundreds. The implication of this is that the unstructured, time and resource-intensive (“Old World”)
approaches to data collection and supply chain communication no longer suffice. Rather, companies seeking
to stay ahead of enforcement authorities are recognizing the need for more sophisticated, proactive (“New
World”) approaches to REACH compliance.

Meeting Additional SVHC Compliance Requirements

Under the EU Waste Framework Directive (WFD), companies in scope of the REACH Regulation
must collect a set of additional data fields for any parts containing SVHCs. This data is then
packaged and submitted to the new Substances of Concern In articles as such or in complex
objects (Products) (SCIP) database.

Failing to comply can result in repercussions that are similar to those for REACH non-compliance,
and enforcement is managed by the same organizations within each respective member state, as
well as additional EU working groups.

Supply chain data technology can acquire, validate, and streamline any range or type of product
data from your supply chain, and keep it synced with the SCIP database. This will help mitigate risk
and maintain access to the EU selling region.

Download eBook For more information about these mandatory requirements, download our eBook, Understanding
EU Waste Framework Directive & SCIP Database Reporting.

24 THE REACH Handbook: Your Guide to SVHC Compliance

“New World” approaches are those characterized by
automation, agility and accuracy in function and performance.
Supply chain data management solutions such as the
Assent Compliance Platform can help make these essential
characteristics a reality for your compliance program by
offering a unique REACH software solution that helps you
track and manage your supply chain communications and data
from one centralized location. Backed by a dedicated supplier
engagement team that collects, analyzes and organizes the
substance information in your supply chain, and a team of
regulatory experts that ensures you remain up to date on
your requirements, your REACH program will be prepared for
success, no matter how the REACH Regulation changes in
the future.

RN
LEA RE
MO
For information on how to get started
with a “New World” supply chain data
management solution that scales alongside
your company and grows in tandem
with regulatory expansions, contact
info@assentcompliance.com.

THE REACH Handbook: Your Guide to SVHC Compliance

25
 WHO IS ASSENT?
Assent is the global leader in supply chain data
management. Combining leading-edge technologies
with extensive supply chain expertise, Assent provides
SaaS solutions that manage third-party data to protect
corporate brands, increase market accessibility, and
reduce operational and financial risk.

WHAT WE DO
Assent provides cloud-based SaaS solutions that
help companies identify and assess risk in their
supply chains, educate stakeholders on regulatory
and data program requirements, and increase
transparency between businesses. Our world-class
support services and regulatory expertise ensures
companies have the guidance and resources they
need to ensure program success.

26 THE REACH Handbook: Your Guide to SVHC Compliance

I didn’t really start enjoying
compliance until I started
working with Assent.
—BILL WHEATLEY
FORMER DIRECTOR OF STRATEGIC PROJECTS
$1.5 BILLION MARKET CAP MEDICAL DEVICE COMPANY

$400,000–$500,000
in annual savings

10,000–12,000
working hours saved

INDUSTRY-SPECIFIC SOLUTIONS FOR:

ELECTRONICS OIL & GAS RETAIL AUTOMOTIVE

MEDICAL INDUSTRIAL AEROSPACE

DEVICES EQUIPMENT & DEFENSE
 Assent Compliance
Platform
Assent Compliance
Platform
The Assent Compliance Platform is the leading supply
chain data management solution. It enables companies to:

§ Automate data acquisition, validation and management

from a centralized, workflow-driven cloud interface.
§ Reallocate resources toward core business activities.
§ Mitigate a broad range of risk.

Developed by a rapidly-growing team of talented product

engineers, the platform is driven by leading-edge
technology and guided by Assent’s regulatory expertise,
making the platform the essential supply chain data
management solution.

REGULATORY TEAM
Assent’s Regulatory team is comprised of subject matter experts with more
than 100 years of combined experience in product compliance, corporate social
responsibility and vendor management. Our team of experts are global leaders
in their respective fields and contribute to establishing industry standards.

ASSENT UNIVERSITY
Assent University facilitates stakeholder and supplier education and training
with expert-created courses. As an integral part of our comprehensive supply
chain data management solution, Assent University provides informative

ent content to support your regulatory education and due diligence requirements.

M
ent
M
ance
DATA & NETWORK
Assent works with a network of over 250,000 manufacturers for real-time access to

rm
28
supplier contact data, with a database that increases by thousands of records per day.
OUR GLOBAL OFFICES

ASSENT COMPLIANCE INC.

CANADA
525 Coventry Road
Ottawa | ON | K1K 2C5
Canada

MALAYSIA
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Penang
39, Jalan Sultan Ahmad Shah
10050 Penang

NETHERLANDS
Barbara Strozzilaan 101
1083 HN | Amsterdam
Netherlands

UNITED KINGDOM
Longcroft House
2-8 Victoria Avenue
Bishopsgate
London | UK | EC2M 4NS

UNITED STATES
301-22 East Gay Street
Columbus | OH | 43215
1 866 964 6931
U.S.A.
assentcompliance.com
info@assentcompliance.com
 525 Coventry Road
Ottawa | ON | K1K 2C5
Canada

1 866 964 6931

info@assentcompliance.com
assentcompliance.com

PC-EB-200618