FORUM Substances in Articles Pilot project report Harmonised

FORUM

Substances in Articles

Pilot project report

Harmonised Enforcement Project

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Disclaimer

This publication is solely intended for information purposes and does not necessarily

represent the official opinion of the European Chemicals Agency. The European Chemicals

Agency is not responsible for the use that may be made of the information contained in

this document.

This report presents the results of inspections made under the Forum enforcement project.

Duty holders and substances selected for checks were those that were relevant for the

scope of the project. The project was not designed as a study of the EU-EEA market. The

number of inspections for individual countries is varied. Accordingly, the results presented

in the report are not necessarily representative of the situation in the EU-EEA market as a

whole.

FORUM PILOT PROJECT SUBSTANCES IN ARTICLES PROJECT REPORT

Harmonised Enforcement Pilot Project on Substances in Articles

Reference: ECHA-2019-R-15-EN

ISBN: 978-92-9481-159-2

Cat. Number: ED-01-19-851-EN-N

DOI: 10.2823/846508

Publ.date: November 2019

Language: EN

Cover page © European Chemicals Agency

If you have questions or comments in relation to this document please send them (quote

the reference and issue date) using the information request form. The information

request form can be accessed via the Contact ECHA page at:

http://echa.europa.eu/contact

European Chemicals Agency

Mailing address: P.O. Box 400, FI-00121 Helsinki, Finland

Visiting address: Annankatu 18, Helsinki, Finland

Version

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Change made

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First edition

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Table of Contents

1. SUMMARY ..................................................................................................... 4

1.1. Content of the project ................................................................................... 4

1.2. Legal obligations .......................................................................................... 4

1.3. Key findings ................................................................................................ 4

2. DETAILED RESULTS OF THE PROJECT ........................................................... 5

2.1. General overview ......................................................................................... 5

2.2. Coordination of the project ............................................................................ 6

2.3. Participation and number of inspections .......................................................... 6

2.4. Type of companies inspected and type of articles targeted. Procedures in place ... 7

2.5. Infringements .............................................................................................20

3. CONCLUSIONS AND RECOMMENDATIONS ................................................... 35

3.1. Conclusions ................................................................................................35

3.2. Recommendations .......................................................................................36

Annex I – Project questionnaire ............................................................................39

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Summary

Content of the project

The Forum carried out a pilot project to control substances of very high concern (SVHCs)

on the Candidate List

(CL substances) in articles sold on the European market

("Substances in Articles"- called SiA). This enforcement project focused on the notification

and communication obligations regarding CL substances in articles under Articles 7(2) and

33 of the REACH Regulation

The operational phase took place from October 2017 until December 2018. In total, 15

Member States participated and 405 companies were inspected and 682 articles checked.

The project targeted consumer articles (i.e. clothing, footwear and home textiles),

electronic products, interior articles and plastic and rubber articles.

Legal obligations

The Candidate List (CL) is a list of substances of very high concern which are "candidates"

for inclusion in Annex XIV, the authorization list in REACH and may be subject to

restrictions. The CL is established by Article 59(1) of REACH Regulation.

According to Article 33, substances which are on the CL are allowed in articles, but

companies must inform professional customers about the presence of those substances no

later than on the supply of the articles and provide sufficient information to allow the safe

use of articles. If a consumer asks, they have to be informed within 45 days, free of charge.

Article 7.2 states the circumstances where these substances have to be notified to the

European Chemicals Agency (ECHA).

Key findings

From the 682 articles inspected, 84 (12 %) contained CL substances in concentration above

0,1 % w/w. Determining whether the article in question contains a CL substance poses

challenges. The project targeted a few CL substances. Phthalates (mostly DEHP) were

found the most (in 51 out of 84 articles) followed by SCCP (short chain chlorinated

paraffins), ADCA (azodicarbonamide) and lead. Phthalates and SCCP were found in soft

plastic materials. ADCA was found in foamed material such as in yoga mats and the softer

inside lining of a hockey helmet.

Out of these CL substance-containing articles, the non-compliant articles and the

deficiencies in the information flow through the supply chain is described below. Also

included in this report are recommendations for different stakeholders – see chapter 3.2

Recommendations.

1.3.1 Article 7(2)

The notification obligation did not apply in most inspected cases, and where it did, the

company complied with the obligation. There was no non-compliance found.

https://echa.europa.eu/candidate-list-table

Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning Registration,

Evaluation, Authorisation and Restriction of Chemicals (REACH)

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1.3.2 Article 33

If an article contains a substance on the CL above a concentration of 0,1 % w/w, the

information regarding this substance must be passed on to all company customers. The

information must be given to consumers upon request within 45 days, independently of

whether the article was purchased or not. 89 % and 56 % of the inspected articles that

contained CL substances above 0,1 % w/w, were found non-compliant with the

requirements of Article 33(1) and Article 33 (2) respectively. So when CL substances are

found in concentrations above 0,1 % w/w, it is also likely that the companies do not fulfil

the communication obligations and therefore non-compliance occurs.

For most of the articles where information obligation existed, the project found deficiencies

on the information on the presence of the CL substance throughout the supply chain. In

73 % of the cases, the inspected company did not give the information to their customer

and in 86 % of the cases the inspected company had not received the information from

their supplier of the articles. This shows that there is a big gap in communication

throughout the supply chain and many of the suppliers are outside of the EU.

Therefore, the companies that buy the products must actively ask their suppliers for the

information on the presence of CL substances, thus ensuring the flow of information in the

supply chain.

Detailed results of the project

General overview

At Forum-22 plenary meeting, the Forum decided to initiate a Forum pilot project on

Substances in Articles that would focus on enforcement of Articles 7(2) and 33 of the

REACH Regulation. The manual was drafted during 2017 by a dedicated Forum Working

Group (WG). Inspections were carried out during 2017 – 2018 and coordinated at national

level. Reporting and evaluation of national feedback took place in 2019.

The notification and communication obligations regarding CL substances in articles (SiA)

under Articles 7(2) and 33 of REACH have not been widely enforced throughout the EU

before this pilot project, despite the suspected high rate of non-compliance with the SiA-

related REACH obligations (e.g. results from enforcement activities in some MSs, low

number of SiA notifications received by ECHA under Article 7(2), NGO and authorities’

reports). This situation could hinder one of the objectives of REACH, namely ensuring safe

use of chemicals in produced and imported articles, in particular in articles to be used by

consumers. In addition, it also appeared necessary to raise awareness regarding the legal

developments on the matter (e.g. Court case C-106/14).

The legal requirements related to the scope of this pilot project were the Articles 7(2) and

33 of the REACH Regulation. The main objective of this project was to check compliance

with Articles 7(2) and 33(1) of the REACH Regulation by all types of suppliers of articles

(including e-commerce) with a main focus on producers and importers of articles. In this

project, the enforcement of obligations to communicate information to consumers (Article

33(2)) was optional. This pilot enforcement project contributes to get a better estimation

of the actual level of compliance with these REACH obligations and identify the reasons for

non-compliance and possible corrective actions (e.g. support to duty holders). The project

should also allow gathering experience and establishing enforcement methods for checking

these obligations in a larger scale (e.g. other duty holders and groups of articles), in the

future.

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Consequently, the main aims of the pilot project were:

• enforcing Articles 7(2), 33(1) and optionally 33(2) of the REACH Regulation by

checking compliance of all types of suppliers of articles with their obligations, but

focusing more on producers and importers of articles;

• contributing to raise awareness and understanding of the legal obligations and

to raise the level of compliance amongst duty holders;

• getting a better picture of the actual level of compliance within suppliers of

articles;

• identifying the reasons for non-compliance, in order to prepare possible

supporting actions (e.g. support to duty holders) by ECHA, the Commission and

Competent Authorities of Member States (MSCAs);

• gathering experience and establishing enforcement methods for checking these

obligations on a larger scale in the future.

The basis for inspections was documentation checking with the possibility to complement

it with chemical analysis. The details about the target duty holders, groups of articles, and

on the CL substances that could be tested by chemical analysis as well as the proposed

procedure were included in the manual.

Coordination of the project

The project was prepared by a Working Group (WG) of the Forum steered by the Forum.

A national coordinator (NC) was nominated to the project by each participating country.

The WG developed the project manual and prepared and delivered the training for NCs.

The WG organised a webinar and a WebEx for NCs during the operational phase. NCs

organised training for inspectors at national level before the inspections started and

reported proceedings of the project before every Forum meeting during the operational

phase. NCs reported the results of the inspections to the WG by using the reporting tools

prepared for the project by ECHA Secretariat. The WG analysed the reported data,

evaluated the results and prepared the project report. The project report has been

consulted with the Forum and approved by the Forum.

Participation and number of inspections

15 Member States participated in the operational phase of the pilot project, with a total

of 405 companies inspected and 682 articles checked.

Table 1 details the number of companies inspected and the number of articles checked

by each participating country.

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Table 1: Participating countries, number of companies inspected and number of

articles checked

Member State

No. of

companies

No. of

articles

Member State

No. of

companies

No. of

articles

Austria (AT)

Italy (IT)

Belgium (BE)

Lithuania (LT)

Czech

Republic (CZ)

21 79

Luxembourg

(LU)

6 31

Estonia (EE)

Latvia (LV)

Finland (FI)

Norway (NO)

Germany (DE) 48 64

Sweden (SE) 75 209

Greece (EL) 33 40

Slovenia (SI) 10 10

Hungary (HU) 41 41

TOTAL:

405

682

Type of companies inspected, type of articles targeted and procedures

in place at company level

2.4.1 Types of companies inspected

2.4.1.1 Description of the sample of companies covered by the pilot project

In terms of the NACE classification, the majority of the inspected companies within the

scope of the project belonged to two types of business sectors:

• 128 companies (32 % of all companies) fall into the category ‘manufacturing’ (NACE

codes 10.00-33.99):

o from which companies dedicated to the manufacture of rubber and plastic

products, electric and electronic equipment were the most representative

(more than 50 % of those belonging to this sector);

• 256 companies (64 % of all companies) of companies inspected fall into the

category ‘Wholesale and retail trade’ (NACE codes 45.00 – 47.99):

o from which more than 52 % are retailers. Table 2 provides further details on

the type of business sector of the inspected companies.

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Table 2 - NACE codes: main business sectors of the companies inspected

NACE Classification

No. of

companies

10.00-33.99

MANUFACTURING

130

22.00

Manufacture of rubber and plastic products

26.00

27.00

Manufacture of computer, electronic and optical

products; Manufacture of electrical equipment

28.00

29.00

30.00

Manufacture of machinery and equipment NEC;

Manufacture of motor vehicles, trailers and semi-

trailers; Manufacture of other transport equipment

17.00

18.00

Manufacture of paper and paper products; Printing

and reproduction of recorded media

13.00

14.00

Manufacture of textiles; Manufacture of wearing

apparel

31.00

Manufacture of furniture

Other

100

45.00-47.99

WHOLESALE AND RETAIL TRADE; REPAIR OF

MOTOR VEHICLES AND MOTORCYCLES

256

45.00

Wholesale and retail trade and repair of motor

vehicles and motorcycles

46.00

Wholesale trade, except of motor vehicles and

motorcycles

(Wholesale of household goods)

113

(61)

47.00

Retail trade, except of motor vehicles and

motorcycles

(Retail sale of information and communication

equipment, other household equipment (incl.

textiles, carpets and floor coverings, and furniture),

and cultural and recreation goods (incl. sporting

equipment and games and toys)

134

(68)

100

OTHER

TOTAL:

405

100

Many companies inspected have several roles under REACH (suppliers of articles,

producers of articles (including assemblers) and importers of articles). Table 3 shows the

number of the REACH roles for the 405 companies inspected.

Table 3 – REACH roles of the companies inspected

Role

No. of companies

Supplier of articles

320

• Supplier in the supply chain (B-to-B)

189

• Supplier to the consumer (B-to-C)

203

Article producer (including assemblers)

131

Article importer

161

Only Representative (appointed by non EU producer of

an article)

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Although companies of all category sizes according to the EU

standard scale were included

in the inspections (N=405), at least 70 % are micro, small and medium-sized companies

(SMEs) as shown in Figure 1.

Figure 1 – Rates of inspected company sizes determined according to

Commission Recommendation 2003/361/EC

2.4.1.2 Analysis of the voluntary audits undertaken in the companies to give an

overview of the implemented management structures to fulfil the

relevant legal duties

The management systems in companies have also been assessed as a voluntary audit was

a part of the inspection according to the project methodology. The management system is

not a requirement under REACH. However, since there was the possibility to conduct

voluntary audits of the inspected companies, it was helpful to have an overview of the

management structures that companies have chosen to implement to fulfil the relevant

SiA duties.

2.4.1.2.1 Analysis of general approach of Companies to comply with chemical

legislations

Out of the 405 inspected companies, for 202 companies (about 50 %) an audit of National

Enforcement Authorities (NEA) was undertaken and in 100 cases management systems

were implemented.

Out of the 202 audited companies, only 50 % have a management system. Significantly

more than half of these enterprises with management systems (61 %) use ISO 9000, a

widely spread quality management system. ISO 14000, an environmental management

system, is used by 19 % of these companies. The others are using various individual

systems.

Commission Recommendation 2003/361/EC

23%

(95)

26%

(107)

21%

(87)

18%

(73)

11%

(43)

Micro Small Medium Not SME Not known

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Figure 2 shows in detail the kind of management systems implemented by the cited 100

companies.

Figure 2 – Management systems implemented in a sample of 100 audited

companies

73 % of the total number of audited companies have a team or a responsible person in

charge of the compliance with chemical legislation. This applies in total to 146 companies.

Table 4 shows the distribution of responsibility roles on different figures either internally in

the company or by external consultants. EHS Officers, REACH/CLP officers and ad hoc

teams appeared to be the most common figures. A detailed view of the other roles is

provided in Figure 3 which explores the role “others” listed in Table 4.

Table 4 – Responsibility roles for the compliance with chemical legislation

Role

No.

EHS Officer 65

REACH/CLP officer

Ad hoc teams

Others

ISO 9001

ISO 14000

combination of ISO 9001+ISO

14000 and other

other (textiles, automotive, food)

no information

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Figure 3 – Distribution of other roles of persons/teams in charge of chemical

legislation

60 % of the total number of audited companies have information on hazardous substances

as such, in mixtures and articles handled in the company. This applies in total to 120

companies.

The details on the scope of such information are reported in Figure 4. The focus is broadly

comparable to both regulated substances and specific lists of hazardous or undesirable

substances. These specific lists are developed by the companies themselves or are part of

the delivery terms of the customers.

Figure 4 – Scope of information on hazardous substances available at company

level

Other internal team or person

Compliance team for different

legislations

Management

External advisors

Purchasing and selling

Quality

Product safety officers

Service providers

SVHC Restricted

Substances

Sector-specific list

for hazardous

substances

78 78

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The level of information available in the analysed sample of 120 companies is reported in

Figure 5. This figure shows that about 2/3 of the companies have the necessary information

on each article (individual and complex articles).

Figure 5 – Level of information on hazardous substances available at company

level

In case of “only partial information available”, the companies have reported different

explanations (e.g. difficulty in obtaining data from the supplier, focus only on specific

substances, focus on risk assessment of materials).

Out of the 202 audited companies, 21 companies have other type of information source

(e.g. manufacturer / supplier, other company sites, test reports are available / requested,

SDS).

2.4.1.2.2 Analysis of the knowledge and procedures, etc. in connection to SiA

obligations

Overall, the proportion of audited companies having knowledge of the actual list of CL

substances was 72 %, corresponding to 144 companies. The number of companies with

information available on CL substances in their articles was 171 (85 %).

In Figure 6, the details of information source in such cases are reported. Most companies

rely on the information provided by the supplier. However, many companies also actively

ask their suppliers for additional information and another smaller part of the companies

carries out its own chemical analysis.

Each

substance,

mixture

Each article

(individual

articles,

complex

object)

Individual

articles

In complex

object

Only partly

available

Complex

objects

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Figure 6 – Source of information on CL substances in articles

2.4.1.2.3 Analysis of the cooperation and experience with suppliers

57 % of the audited companies reported to have an assessment scheme for suppliers. This

applies in total to 117 companies. Figure 7 shows the resulting main assessment schemes

for suppliers available in those companies.

Figure 7 – Main assessment schemes for suppliers

It has to be noted that out of the 117 companies having an assessment scheme for

suppliers, only 56 companies reported that relevant information on CL substances is

included in such scheme. In total only 31 companies have downgraded or rejected a

supplier because of weak information on CL substances.

0 20 40 60 80 100 120

Other

Literature

Experiences of consultants

Carry out own chemical analysis

Actively asking suppliers for information

Rely on information given by the suppliers

117

0 2 4 6 8 10 12 14 16 18 20

other systems

not reported

agreement with suppliers

supplier deliver to EU companies

IMDS - International Material Data System

internal database

registry of approved suppliers

general supply contracts/declarations

past experience with suppliers

supplier evaluation systems (e.g. audit)

based on standard management systems

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In terms of cooperation and experience with suppliers, the proportion of audited companies

having ever received information from suppliers about the presence in the articles of CL

substances in concentrations above 0.1 % w/w and/or information on the related safe use

was 18 %, corresponding to 36 companies.

2.4.2 Types of articles inspected

2.4.2.1 Analysis of the specific articles and their most relevant CL substance

The 682 articles inspected in this project belonged to four main groups as summarised in

Table 5 below, 40 % of them being components of complex objects

. The Table also shows

the number of articles in each group which contain CL substances in a concentration above

0,1 % w/w.

Table 5 – Types and figures for inspected articles

Group

No. of

checked

articles

(%)

No. of articles with

CL substance(s)

above 0.1 % w/w

(%)

1. Consumer articles: consumer

clothing and footwear, and home

textiles

133

(20)

(13)

2. Electric/electronic products:

wires and cables and

electric/electronic accessories

(11)

(24)

3. Building, interior articles:

plastic or textile floorings, wall

coverings and plastic furniture

(10)

(3)

4. Other: other plastic and

rubber articles.

406

(60)

(12)

TOTAL:

682

(100)

(12)

From the 682 articles inspected, 84 contained CL substances in a concentration above 0.1

% w/w. The distribution of the CL substances present in these 84 articles is given in Table

6. In the sample of articles inspected, only the CL substances checked are reported in

Table 6. Some articles contained more than one CL substance. Not all of the CL Substances

considered in the project were found in the sample of articles inspected.

See definition in subchapter 2.4 of the Guidance on requirements for substances in articles

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Table 6 – Distribution of CL substances present in the inspected articles

CL substances

No. of

articles

Notes

Phthalates

- Bis(2-ethylhexyl)

phthalate (DEHP) is the

most representative

(present in 36)

Short-chain chloroparaffins (SCCP)

Diazene-1,2-dicarboxamide (C,C'-

azodi(formamide)) (ADCA)

Lead

Cadmium

Bisphenol A

Brominated flame retardants (DecaBDE,

HBCDD)

Aprotic polar solvents (DMF/DMAC)

Perfluorinated substances

Phenolic benzotriazoles

Phosphorous flame retardants (TCEP, TXP)

2.4.2.2 Analysis of the methodology for getting the information on the

concentration of CL substance

The 682 articles inspected in this project were checked for the content of CL substances.

In Table 7, the different sources for obtaining the content of CL substances are listed. In

78 % of the cases the information came from chemical analysis. Most of the chemical

analysis was done by the inspecting authority (69 %). In five cases, the chemical analysis

was done both by the supplier of the inspected company as well as the inspecting authority.

In five other cases, the chemical analysis was done by the inspected company as well by

the supplier of the inspected company. In 24 cases, the entity responsible for the chemical

analysis was not specified. Out of the 84 articles which contained CL substances in a

concentration above 0,1 % w/w, 81 of them were checked by chemical analysis. 78 out

of the 81 articles were checked by the inspecting authority. For 42 articles out of the 84

articles that contained CL substances, the results of the chemical analyses where not in

line with the information given by the company. In 9 % of the cases the information was

given by the inspected company or by its supplier (12 %). In eight cases the information

was provided by other sources.

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Table 7 – Sources of information to obtain the content of CL-substances

Source of information

No. of articles

(%)

Notes

Chemical analysis

529

(78)

mostly by

the

inspecting

authority

- By the inspected company

19 (3)

- By a supplier of the inspected

company

23 (3)

- By the inspecting authority

473 (69)

Information given by the inspected

company

63 (9)

Information given by the supplier of the

inspected company

82 (12)

Other sources

8 (1)

2.4.3 Procedures in place at company level

The project collected information on procedures and management tools used to fulfil the

information requirements according to Article 33 and Article 7(2). As already described in

chapter 2.4.1.2.1, only about 50 % of the investigated companies have a general

management system.

Figure 8 shows the number and percentage of companies with procedures to meet the

requirements of Articles 33 and 7 (2). 35 % of companies have such a specific management

system; 36 % have no system implemented. 10 % of the companies have systems only

partly in place; 13 % were not checked and 6 % of the companies have other

measurements implemented.

Figure 8 – Procedures implemented to fulfil the information requirements of

Article 33 and/or Article 7(2) (Number; %)

Companies with the option "other" usually stated that this question was not relevant for

Yes, 141,

35%

Partly, 40,

10%

No, 145,

36%

Not

checked;

55; 13%

Other, 24,

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them or that their products do not contain CL substances or that there is no need for

specific procedures.

The most commonly used systems for monitoring and complying with legal requirements

are declarations of conformity and product declarations. This is information provided by

the supplier. Also very common are specifications for substance restrictions by the

company. These include lists of restricted substances as well as the complete ban of CL

substances in articles. Details are shown in Table 8.

Table 8: Specification of General Procedures used to fulfil the requirements

(Absolute numbers)

Procedures

Counts

Declarations of compliance with Art 33 / Art 7(2) 61

A praxis not to sell articles that contain CL substances 58

Third party certification 41

Other 41

Restricted substances list (with CL substance) 38

Bill of materials/articles specifying CL substances 33

Product declarations related to Art 33 / Art 7(2) 33

IT platform/database 12

Only a few companies claim to carry out their own laboratory analyses. Some companies

also use the information from the SDS to comply with the legal requirements.

When taking the size of the company into consideration, this reveals a quite clear

connection between the size of the company and the implementation of procedures. Around

50 % of medium and non-SME companies have at least partially implemented such

procedures, while only 30-40 % of small and micro companies have such tools in place.

Detail are shown in Table 9.

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Table 9: Percentage of Procedures to fulfil information requirements vs.

company size

When selling products containing more than 0.1 % w/w CL substances, the company is

required to provide the necessary information for safe handling to customers. In each case

the substance name must be stated.

Subsequently, the companies were asked if additional procedures or information on the

CL substances were provided to customers. More than half (54 %) of all surveyed

companies did not provide any further information or procedures. Only 16 % of the

companies have additional voluntary general procedures implemented.

Table 10: Number of companies with additional voluntary general procedure

implemented

Add.

Procedures

Count

Percentage

Yes

16 %

219

54 %

Not checked

120

29 %

Grand Total

405

Most of these companies provide additional information via the labels, pictograms or user

manuals. Some companies use their website to communicate information in both

directions, towards the consumer and the supplier. Overall, nine companies give additional

information for safe handling. One company provides a mobile app with additional

information.

not SME Medium Small Micro Not Known

Yes

40 43 32 23 44

Partly

8 10 9 8 16

26 26 43 46 30

Not checked

15 9 10 22 9

Other

11 11 6 0 0

Percentage (%)

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Table 11: Additional Procedures to inform about CL Substances

The last question of this section asked about the implementation of the European Court of

Justice’s (the Court) decision on the definition of products. According to that decision, in

the case of complex objects the reference value for calculating the concentration of a CL

substance is the individual product. Only around 50 % of the companies surveyed stated

that they had implemented the decision. The other companies have not yet integrated this

decision into their process. This does not necessarily mean that these companies do not

act in accordance with the law. The Court decision only has a direct impact on information

and notification obligations if the products are complex and CL substances are present in

small components.

Additional Procedures in Place

Count

Information on labels

Other

Information in accompanying documentation (e.g. in instruction

for product use)

Labelling pictograms

Providing information to (databases of) Article 33(2) Phone

Apps

In instructions for safe use

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Table 12: Implementation of the new interpretation of an article

Implementation of Court

decision

Count

Yes

Not checked

273

Grand Total

405

Infringements

The following results of the enforcement project are related to the inspected articles and

companies.

2.5.1 Article 33(1)

Summarised observations on non-compliance

From the total amount of 682 inspected articles, fulfilling the two following conditions:

• the concentration of CL substances is above 0.1 % w/w;

• the inspected company has the role of a B-to-B supplier (business to business

supplier);

the obligation, according to Article 33(1) of REACH, exists for only 45 articles. From these

45 articles the information obligation was fulfilled in five cases and was not fulfilled in 40

cases. Therefore, the non-compliance rate concerning the articles with information

obligation for the duty holder, was 89 % (Figure 9).

Figure 9 – Compliant and non-compliant articles related to Article 33(1) of REACH

From the total amount of 405 inspected companies the obligation according to Article 33(1)

of REACH was considered to exist in only 42 cases. From these 42 companies the

information obligation was fulfilled in five cases and was not fulfilled in 37 cases. Therefore,

the non-compliance rate concerning the companies with information obligation for the duty

holder, was 88 % (Figure 10).

non-compliant articles compliant articles

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Figure 10 – Compliant and non-compliant companies related to the information

obligations according to Article 33(1) of REACH

CL-substances in non-compliant articles

The following CL substances were identified in concentrations above 0,1 % w/w in the 40

articles for which the communication duty under Article 33(1) of REACH was not fulfilled

(Figure 11):

• different phthalates in 29 cases;

• SCCP in eight cases;

• ADCA in six cases;

• cadmium in one case.

To note: sometimes several substances were found in one article.

Figure 11 –Number of non-compliant articles according to Article 33(1) of REACH

and relevant substances identified

compliant companies noncompliant companies

Short-chain

chloroparaffins (SCCP)

Phthalate ADCA Cadmium

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Data source and non-compliance

In all cases of non-compliance according to Article 33(1) of REACH, the non-compliance is

identified from data obtained by chemical analysis. 95 % of these analysis were performed

by the Authority.

Sector and non-compliances

Within the non-compliant articles, the sector where the most non-compliance was found

was in the group of “other plastic and rubber articles”, with 18 cases of non-compliance.

These were followed by 12 cases in the group of consumer clothing, footwear and home

textiles, nine cases in the group of wires and cables and electric / electronic accessories

and one article in the group of plastic or textile flooring, wall coverings and plastic furniture

(Figure 12).

Figure 12 – Types of non-compliant articles related to Article 33(1) of REACH

Non-compliance and Complex object

The non-compliance according to Article 33(1) was found mostly in components of a

complex object, specifically in 25 articles. The other 15 cases of non-compliance were

found in single or “stand alone” articles, i.e. the article is not a component in a complex

object.

Non-compliance and company size or role of the company

Regarding the size of the non-compliant companies, the conclusion was that five were not

SME companies, implying that 86 % non-compliant companies are SME companies (Figure

13).

Consumer clothing, footwear and home textiles

Wires and cables and electric‘/electronic accessories

plastic or textile flooring, wall coverings and plastic furniture

Other plastic and rubber articles

Micro Small Medium not SME

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Figure 25 – Role of non-compliant companies related to the information

obligations according to Article 33(2) of REACH

Non-compliance and management system

Management systems help companies fulfil their legal duties. Most of the non-compliant

companies had no management system implemented, whereas only three of the non-

compliant companies had a management system implemented (Figure 26).

Figure 26 – Relationship between the implementation of a management system

and the non-compliance in relation to the information obligations according to

Article 33(2) of REACH

The availability of information on hazardous substances as such, in a mixture or in an

article handled in the company is one important aspect of a management system. The

inspections revealed that in two non-compliant companies, this information was available

on different levels (for each substance or mixture, each article as an individual article or

articles within complex objects) (Figure 27). However, in five non-compliant companies no

information on hazardous substances was available (Figure 27).

supplier B-to-C article producer article importer

yes no

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Figure 27 – Relationship between the availability of information on hazardous

substances in the company and the levels of the availability of the information in

companies not complying with the information obligations according to Article

33(2) of REACH

Within the non-compliant companies according to Article 33(2), the source of information

on the CL substances present in their articles varied. Four companies had no information.

Four had information and they mostly relied on information given by suppliers, some even

asking suppliers actively for information (Figure 28).

Figure 28 – Relationship between the availability of information and the source

of information on CL substances in companies not complying with the information

obligations according to Article 33(2) of REACH

1 1 1 1 1

yes each

substance,

mixture

each

article

(individual

article,

complex

object)

individual

article

in complex

object

partly

available,

e.g.

exposure

complex

object

4 4

0 0 0

information rely on

information

given by the

suppliers

actively

asking

suppliers for

information

carry out

own

chemical

analysis

expriences

consultants

literature no

information

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Consumer request

On request by a consumer, any supplier of an article containing a CL substance in a

concentration above 0.1 % w/w shall provide the consumer with sufficient information

available to the supplier, to allow the safe use of the article including, as a minimum, the

name of that substance. Information obligations according to Article 33(2) are related to a

consumer request. For 46 articles, no consumer requested the information according to

Article 33(2). For five articles, consumers requested the information according to Article

33(2). For four of the articles, the information was not provided in 45 days (Figure 29).

The results show that the decision related to non-compliance of Article 33(2) was taken by

the NEAs also when no consumer requested the information according to Article 33(2).

Based on the available results the WG would summarize that NEA probably decided that

information obligation according to Article 33(2) was not fulfilled when the article was

supplied to a consumer and the inspected company was not able to provide the correct

information to NEA. In case of a consumer request, the inspected company would also not

have provided the consumer with the correct information.

Figure 29 – Requested information from consumers to suppliers. Required

information provided to consumers according to Article 33(2) of REACH

Summary: Article 33(2)

The results show a high non-compliance rate of 56 % for the articles with information

obligations according to Article 33(2) and also a high non-compliance rate of 51 % for the

duty holder with this information obligations according to Article 33(2). Related to the

articles with information obligations according to Article 33(2), it is noted that only a few

consumers requested information.

yes no other If yes - required

information in 45

If yes - required

information not

in 45 d

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2.5.3 Legal actions

Legal actions were initiated against the non-compliant company for 45 cases and 13 cases

were still on-going after the project was completed at national level. The enforcement

measures used by NEAs were (see Figure 30):

• written advice was the most used enforcement measure with 26 cases following the

administrative order (or enjoinment) with 14 cases by the NEA;

• voluntary action by the company, meaning withdrawal from the market (including

sales stops), were made for 16 cases and in one instance, a company voluntarily

recalled product(s) from its customers;

• in seven cases non-compliant products were prohibited from being placed on the

market and in five cases products were withdrawn from the market;

• verbal advice was used in four cases;

• public announcement by the enforcement authority i.e. “Name and Shame” in two

cases; no articles had to be recalled from consumers;

• in one case no enforcement measure against the company was possible because of

the bankruptcy of the company; and

• one case was forwarded to another enforcement authority.

Figure 30 –Enforcement measures and other actions for non-compliant cases

related to SiA duties (please note that several measures could be relevant in one case)

Regarding sanctions, a criminal complaint and/or handing over to NEA public prosecutor's

offices was a result in 21 cases and fines were given for two cases. For two cases, the

sanctions were still unknown at the end of the project (See figure 3).

1 1

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Figure 31 – Sanctions for non-compliant cases related to SiA duties (please note

that several measures could be relevant in one case)

2.5.4 Communication between Member States

Participants of the project were asked if they used ICSMS, RAPEX or PD-NEA

communicate information on their detected non-compliant cases. Altogether 11 non-

compliant cases were communicated to other MSs, 10 via ICSMS and one by some other

mechanism not reported (Figure 32). Also, many compliant cases were communicated to

other MSs by ICSMS.

Figure 32 – Communication mechanism for cases of non-compliance with SiA

duties

ICSMS: Information and Communication System on Market Surveillance; RAPEX: Rapid Alert System

for Non-Food Consumer Products ; PD-NEA: Portal Dashboard for National Enforcement Authorities

Criminal complaint / handing over to public prosecutor's office

Fine

Admonition

Unknown

Other

ICSMS other

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Conclusions and Recommendations

Conclusions

15 Member States participated in the operational phase of the pilot project, with a total of

405 companies inspected and 682 articles checked.

Out of the 682 articles inspected, 84 contained CL substances in a concentration above

0.1 % w/w. Phthalates (mostly DEHP) were found in most (51 articles), followed by SCCP,

ADCA and lead. Phthalates and SCCP were found in soft plastic materials especially PVC.

ADCA was found in foamed material such as in yoga mats and hockey helmets. Out of the

84 products which contained CL substances in concentration above 0,1 % w/w, 81 were

checked by chemical analysis, and out of these cases, 78 (96 %) were checked by the

authorities. This indicates that it is important for NEAs to carry out their own chemical

analysis when enforcing these obligations.

57 out of 201 (28 %) companies do not have knowledge about the CL and 50 % of the 202

audited companies do not have a general management system. The most commonly used

systems for monitoring and complying with legal requirements are declarations of

conformity

and product declarations. This is information provided by the supplier. Also

very common are specifications for substances (which restrict the presence of certain

substances in articles) adopted by companies towards their suppliers who are given a

“black list for substances”. These include lists of restricted substances as well as the

complete ban of CL substances in articles. Only few companies claim to carry out their own

laboratory analyses. Some companies also use the information from the safety data sheet

to comply with legal requirements.

Taking the size of the company into consideration reveals a quite clear connection between

the size of the company and the implementation of procedures. Around 50 % of medium

and non-SME companies have at least partially implemented such procedures, while only

30-40 % of small and micro companies have such tools in place.

3.1.1 Article 7

The notification obligation did not apply in most inspected cases, and where it did, the

company complied with it. There was no non-compliance found. The checks of the

compliance with the notification obligation rely on the information provided by the

companies and therefore companies should organise their records well and show clearly

that they follow the ECHA’s Guidance on requirements for substances in articles.

3.1.2 Article 33

The selection of articles focused on high risk products or materials. 12 % of articles

contained CL substances in a concentration above 0,1 % w/w. Determining whether the

article in question contains a CL substance poses challenges. The project targeted only a

few CL substances.

The information provided under Article 33(1) shall enable safe handling of the article and

shall contain the name of the substance of very high concern. 89 % and 56 % of the

inspected articles that contained CL substances above 0,1 % w/w, were found non-

compliant with the requirements of Article 33(1) and Article 33(2) respectively. So when

Note that legal obligations for EU Declaration of conformity (DoC) only exists for CE labelling directives

such as Toys and RoHS directive. There is no legal obligation for DoC for REACH.

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CL substances are found, it is likely that also non-compliance occurs.

Even though it is allowed to sell articles that contain CL substances, some companies state

that they do not want to sell articles that contain CL substances (58 companies).

One aspect of this project was to investigate if the information flow is working in the supply

chain. The finding was that for most of the articles (86 %) where there was an information

duty, the inspected company had not been informed by its supplier about the presence of

CL substances. This shows that companies need to set demands on their suppliers to

ensure that information flows through the supply chain. For high risk materials, it is also

advisable for suppliers and recipients of articles to do chemical analysis from time to time.

In a long supply chain, raw material suppliers may change, and it might be difficult to

secure the information flow. In 73 % of the non-compliant articles, the recipient had not

received the relevant information from the inspected supplier. For only three articles, the

inspected supplier informed the recipient according to Article 33(1).

For the non-compliant companies, 86 % were either micro or SME companies. This

indicates that smaller companies are less aware of their obligation regarding CL

substances. For the companies that were audited, none of the non-compliant SME and

micro-sized companies had implemented a management system (ISO 9001, ISO 14000,

EMAS, etc.). Only about 20 % of the non-compliant micro and SME companies had

implemented a general procedure to fulfil the information obligation of Article 33 and Article

7(2). Examples of procedures were restricted substance list, declaration of compliance,

third party certification and a practise not to sell articles that contain CL substances.

According to Article 33(1) the recipient of an article has to be informed by its supplier with

the required information. In 86 % of articles where information obligations existed, the

inspected company had not been informed by their supplier with the required information.

In 73 % of the non-compliant articles the recipient had not received the relevant

information from the inspected supplier. This shows that there is a big gap in the

communication trough the supply chain.

Recommendations

The following recommendations are a result of the experiences gained in this project.

3.2.1 Recommendations to industry

● The results show that the information through the supply chain can improve

significantly. The improvement needs to come twofold:

o duty holders need to observe their communication duties on CL substances

in articles;

o in addition, they have to take action and shall set clear demands on their

suppliers about CL substances and do random chemical analysis.

● Choose suppliers wisely, consider what to demand or ask for, and what to pay

particular attention to.

● The requirements of Article 33 and 7 (2) impose high demands on companies. On

the one hand, these are only information obligations that have to be provided by

the supplier. On the other hand, the practice has shown that these information

obligations of suppliers are often not met. In addition, important information about

CL substances sometimes disappears along multi-level supply chains or never

existed in the supply chain.

As a rule, the company cannot rely on receiving the required information without

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its own activity. Each company should therefore define a procedure to obtain the

required information. This procedure can be integrated into the general

management system. This can be, for example, the quality management system.

However, independent procedures are also possible, such as contractual

agreements with the suppliers. Many companies rely on the information provided

by their suppliers. However, conducting their own chemical analysis may appear

necessary from time to time.

• The results show that the information through the supply chain can improve

significantly. A way to do this is to:

o strengthen the communication with suppliers;

o set clear demands the suppliers about CL substances; and

o do random chemical analysis.

• The results show that in almost all the cases only the name of the candidate list

substance was communicated in the supply chain. However, there are cases where

more information on safe handling should be provided.

• Article 33(2) states that the information about the CL substance should be given

when a consumer request it. Some companies also use additional voluntary

measures by providing additional information via the labels, pictograms or user

manuals. Another way is to use the company’s website to communicate information.

• Adopting quality management system and/or an alternative means of ensuring

traceability through IT systems or tools could help in improving compliance.

• Companies must better organise their records and show more clearly how they take

their decisions in line with the recommendations in ECHA’s Guidance on

requirements for substances in articles.

3.2.2 Recommendation to ECHA / COM / National helpdesks

• As all results show that companies have low level of knowledge about their SiA-

related obligations, the first and most important suggestion to ECHA, COM, and

National helpdesks would be to organise a comprehensive awareness-raising

campaign on SiA duties, including timing and how to follow up of the regularly

updated CL list.

• It is proposed to ECHA, potentially in cooperation with COM and MSs, to develop a

methodology to better target relevant articles for SiA duties and to provide

additional practical guidance (further to those already present in the pilot project

manual) about the proper selection of types of substances to be looked for in certain

types of articles.

• It is also recommended that ECHA develop more guidance on what specific

information is to be provided in the supply chain beyond the name of the

substance(s) and in what cases such information is needed.

• It is possible to get surveillance grants from the DG for Internal Market, Industry,

Entrepreneurship and SMEs for the analyses of products. However, the

administration of the application is quite complicated and hinders Member States to

apply. A suggestion would be to simplify the administrative requirements linked to

the application and ECHA / Forum Secretariat to support MSs using these grants.

3.2.3 Recommendations to National Enforcement Authorities (NEAs)

• Finding non-compliance requires first of all the identification of CL substances in

concentrations above 0,1 % w/w. The identification of these substances in the

articles reveals high degrees of non-compliance with SiA communication duties.

More targeted inspections are needed with more targeted article choices. Attention

has to be paid to the likelihood of presence of the substance in the article, due to

https://echa.europa.eu/guidance-documents/guidance-on-reach

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the function of the CL substance. In this respect, guidance has already been

provided by the pilot project manual.

• Although companies can have multiple roles, in general, inspectors reported higher

degrees of compliance amongst producers of articles and lower degrees of

compliance amongst the importers. Therefore, more checks on importers should be

promoted, in cooperation with customs whenever possible. The benefit would to

address the problem of lack of information and where it frequently originates from

in the supply chain – although it is more difficult to identify importers. When

importers do not have information or do not inform the next company in the supply

chain, the non-compliance is repeated through the whole supply chain.

• Non-compliance is best stated when the presence of a CL substance is examined in

the lab. As laboratory testing is often necessary for such a direction of inspection,

resources need to be allocated already at the planning stage.

• According to the report, there are Member States where the NEAs identify higher

rates of non-compliant articles. It would be very useful to share practices between

Member States on targeting articles.

• Reduction of costs and better organisation of tasks can be achieved by combining

SiA duties with other duties for the same article (e.g. with Reach-restrictions, POPs).

In terms of analysis of articles, the methodology used does not differ.

• For the same reasons as above, it is also suggested that joint inspections with other

national authorities such as customs or other market surveillance authorities are

conducted.

3.2.4 Recommendations to Forum

• Perform a REACH-EN-FORCE (REF) project which includes SiA duties (at least article

33). A combination of SiA duties with other legal requirements applicable to

substances in articles could be considered (e.g. REACH Restrictions, POPs), as

indicated above.

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Annex I – Project questionnaire

PILOT PROJECT QUESTIONNAIRE

Section 1: General Information

Question

Remarks

Company

Address

Contact person

Organisation number

Telephone

E-mail contact person

This data will be

deleted by NC - this

data are only for

internal use e.g. in

case you need to

forward the

questionnaire to

other NEAs for

assistance

Question

Remarks

Participating country

Inspection date

Present NEA

Person in charge (NEA)

Phone

E-Mail

This data will be

deleted by NC - this

data are only for

internal use e.g. in

case you need to

forward the

questionnaire to

other NEAs for

assistance

File Reference

The file reference

needs to match the

file reference in

section 4 for the

articles inspected

and reported in the

company. The format

can be

alphanumerical.

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Section 2: Company information (company

related) – obligatory

NACE-Code of company:

source for NACE

codes, see Annex 5.

Role of the Company under REACH

 supplier of an article

 Supplier in the supply chain (B-to-B)

 Supplier to the consumer (B-to-C)

 article producer (including assemblers)

 article importer

 Only Representative (appointed by non EU producer of

an article)

see REACH Art 3 (33)

see REACH Art 3 (4)

see REACH Art 3 (11)

and Art 3(10)

see REACH Art 8, an

Only Representative

needs to be

appointed by a non

EU producer of an

article

In case of the role of

a distributor

(including a retailer,

see REACH Art

3(14)) please tick

either “supplier in the

supply chain(B-to-B)”

or “Supplier to the

consumer (B-to-C)”

or both, whatever is

applicable

“B-to-B”: business to

business, a supplier

provides an article to

another company

“B-to-C”: business to

consumer, a supplier

provides an article to

a consumer

Definition of the company according to Commission

Recommendation 2003/361/EC

� Micro � Small � Medium

� Not SME � Not known

Micro: <10 employees and ≤2 million euro annual turnover

Small: <50 employees and ≤10 million euro annual turnover

Medium: <250 employees and ≤50 million euro annual

turnover

See the description of the role of an assembler in the Scenario 1 and 2 described in Table 3 of Section

3.2.2 and in footnote 13 in Section 2.4. of the Guidance on requirements for substances in Articles,

Version 4, ECHA June 2017,

https://echa.europa.eu/guidance-documents/guidance-on-

reach?panel=guidance-on-requirements-for-substances-in-articles#guidance-on-

requirements-for-substances-in-articles

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Section 3: Company audit and inspection

(company related)

Section 3a – voluntary

Section 3b - obligatory

Section 3 a) Company audit (company related) (voluntary

section to give an overview of the implemented management

structures to fulfil the relevant legal duties)

Scope of the audit

Has this section been covered by the inspector?

� Yes

� No

If No, go to section 3b

Company’s general approach to comply with chemical legislations

Is a management system implemented?

� Yes

If yes, which kind, please specify :

(Drop down:

ISO 9001

ISO 14000

EMAS

Free text)

� No

management

systems like ISO

9001, ISO 14000,

EMAS, etc. certified

for the company

can be relevant

Is a team or a responsible person in charge for compliance with

chemical legislation?

� Yes

If yes

EHS Officer

REACH / CLP Officer

 Ad-hoc Teams

 Others, please specify

� No

EHS officer:

environment, health

safety officer

Others: please

specify whether a

consultant, service

provider, etc.

Is information on hazardous substances as such, in substances,

in mixtures and articles handled in the company available

� Yes

If yes, what is the scope

 CL Substances (SVHC in Candidate List)

 Restricted Substances (e.g. Annex XVII of REACH)

 Own definition of company list or sector-specific list for

hazardous substances

If yes on which level is information available in the

company

Substances can be

present in

substances (e.g. in

UVCB (Unknown or

Variable

composition,

Complex reaction

products or

Biological

materials)or

multiconstituent

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

Each substance, mixture

 Each article (individual articles, complex object)

 individual articles

 in complex object

 Only partly available, please specify (e.g. only focusing

on exposure / risk assessment

 Complex objects (see note in the column)

� No

� Other, please specify

substances), in

mixtures or in

articles

“complex object” in

the Guidance:

refers to any object

made up of more

than one article,

like coffee machines

or cars.

Please note that

information only on

the level of complex

object is not

allowed unless it is

a substance or a

mixture used to join

two articles (e.g.

solder, glue)

Knowledge and procedures, etc. in connection to SiA obligations

Does the company have knowledge of the actual list of candidate

substances?

� Yes

� No

Knowledge of the

company could also

be not in-house

knowledge but the

knowledge from a

consultant

Examples how the

company get actual

information on new

CL substances:

- Periodical views of

ECHA home page

- Newsletter e.g.

Chamber of

commerce, sector

organisations

- External consultant

How does the company get information on CL substances in their

articles?

� Information:

 Rely on information given by the suppliers

 Actively asking suppliers for information

 Carry out own chemical analysis

 Experiences of consultants

 Literature

 Other, please specify:

� No information

� Not relevant

Producer of articles

need to consult the

Safety Data Sheets

of the raw materials

(substances,

mixtures) for the

presence of a CL

substance)

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Cooperation and experiences with suppliers

Has the company ever received information that an article they

have been supplied with contains substances on the Candidate

List in concentrations above 0.1 % and/ or information on the

related safe use?

� Yes

� No

� Partly

� Not relevant

� Other

Does the company have an assessment scheme for suppliers?

� Yes

If yes, could the scheme be named/described?

If yes, is the relevant information (for SiA) on CL substance

included in the assessment scheme

� Yes

� No

Examples for

assessment criteria:

• REACH-awareness

of the supplier

• results of previous

supplier audits

• likelihood of

restricted

substances being

present in supplied

articles / materials

• experience with

the supplier in the

past

The most popular

scheme is the EN

50581 used under

the RoHS Directive

Did the company ever downgrade/ reject a supplier because of

weak information on SVHC?

� Yes

� No

3 b) Company inspection (company related) - obligatory

Number of articles subject to the SiA duties in the company (not

each batch or each individual product)

� Not known

The answer is only

based on the

information of the

inspected company.

Please provide rough

estimates for the

number of articles.

Number of articles checked by the inspector

Recommended

range: 1 - 10, for

each of the articles

inspected Section 4

of the Questionnaire

should be filled

separately (for each

reported article).

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Is there a general procedure implemented to fulfil the

information requirements of Article 33 and/or Article 7(2)?

� Yes

� No

� Partly

� Not checked

� Other: Free text box

If Yes/partly, please specify:



Bill of materials/articles specifying CL substances

 Declarations of compliance with Art 33 / Art 7(2)

 Restricted substances list (with CL substance)

 Third party certification

 IT platform/database

 Product declarations related to Art 33 / Art 7(2)

 A praxis not to sell articles that contain Candidate list

substances

 Other, please specify:

Please note that the

procedure(s) need to

cover Art 33(1) and

Art33(2) as well as

Art 7(2), where

relevant

Third party

certification: Service

provided by third

parties assessing

products against

certain criteria,

including the content

of hazardous

substances (e.g.

Bluesign®, OEKO-

TEX®, BASTA).

Often this service

also includes a

labelling scheme for

approved products.

platform/database:

An IT

platform/database

into which actors at

different stages of

the supply chain

may enter, manage

and extract

information on

composition of

mixtures, semi-

finished and finished

articles they produce

or use. The system

supports the

sharing/transfer of

information or

declarations

throughout the

supply chain which

allow to track the

relevant composition

of materials/articles

used to produce a

product. Examples:

IMDS, BOMcheck,

Octopus, CDX,

ChemSherpa.

For more

information on the

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tools mentioned in

the list please refer

to the Commission

study available at:

https://publications.

europa.eu/en/public

ation-detail/-

/publication/58f951a

f-809b-11e7-b5c6-

01aa75ed71a1/lang

uage-en/format-PDF

Is there in addition a voluntary general procedure implemented

to fulfil the specific information requirements of Article 33(2) for

consumers?

� Yes:

If yes please specify:

 Information on labels

 Labelling pictograms

 Providing information to (databases of) Article 33(2)

Phone Apps

 In instructions for safe use

 Information in accompanying documentation (e.g. in

instruction for product use)

 Other. Please specify:

� No

� Not checked

The general

procedures are most

often aiming at

providing the

consumer pro-

actively with the

required information

without the need for

an explicit consumer

request.

Existing Labelling

pictograms, e.g.

”Phthalate free”

Phone Apps: e.g.

ToxFox

For more

information on the

tools mentioned in

the list please refer

to the Commission

study available at:

https://publications.

europa.eu/en/public

ation-detail/-

/publication/58f951a

f-809b-11e7-b5c6-

01aa75ed71a1/lang

uage-en/format-PDF

Does the company implement the new interpretation of an

article (Court decision, Guidance, Version 4) and the related

procedures / structures?

� Yes

� No

� Not checked

For background

information on

“complex objects”

see in Section 2.4 in

the Guidance

Pilot project on substances in articles – project report

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Section 4 - Enforcement of CL substances in

selected articles (article related) - obligatory

Questions about specific articles and their most relevant CL substance, etc. to

be filled in for each article

File Reference

The file reference

needs to match

the file reference

in section 1.

EAN / GTIN No.

This data will be

deleted by NC -

this data are only

for internal use

e.g. in case you

need to forward

the questionnaire

to other NEAs for

assistance

Internal identifier (sample no.)

Type of article

Select one of the 4 categories within the scope of the project

�1 Consumer clothing, footwear and home textiles

�2 Wires and cables and electric‘/electronic accessories

�3 Plastic or textile flooring, wall coverings and plastic

furniture

�4 Other plastic and rubber articles

Is the inspected article a component of a complex object?

� Yes

� No

� Other:

For the scope, see

in Section 4.2.1 of

the Manual

Is the concentration of the selected CL substance above (>)

0,1 %:

� Yes

If yes

 Brominated flame retardants (DecaBDE, HBCDD)

 Phosphorous flame retardants (TCEP, TXP)

 Short-chain chloroparaffins (SCCP)

 Phthalates

 Aprotic polar solvents (DMF/DMAC)

Perfluorinated substances

 Phenolic benzotriazoles

 Other: free text

Please indicate which substance by providing the CAS number

or any other identifier when CAS number does not exist:

� No

Please indicate the

most relevant

from those CL

substances for

which the

inspected article

has been checked

for

For a list of

relevant CL

substances, see

Annex 9 of the

Manual

Pilot project on substances in articles – project report

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� Other

On what kind of information is the answer in question 24

((previous answer) based?

� on information from chemical analysis in a laboratory

 by the inspected company

 by a supplier of the inspected company

 by the inspecting authority

� only on the information of the inspected company

� on the information of the supplier of the inspected company

� other:

I. Obligation to notify CL substances in articles according to

Article 7 (2) REACH (article producer, importer)

Has the company (in its role of the article producer or

importer) notified the selected CL substance for the inspected

article according to article 7(2)

� Yes

� No

� Not checked

� Not relevant

Art 7(2) requires

a notification for

a CL substance in

all articles of the

company in which

the CL substance

is present (above

0,1 % in each

article and above

1 tonne) in total)

If yes go to

question 30.

If no go to

questions 27 and

28. Depending on

the best

approach taken

by the inspector,

he/she can start

either by

checking question

27 or question

28.

Not relevant: e.g.

the producer is

an “assembler” of

a complex object

(mechanically

assembling of

articles)

If no in the above question (question 26): - does the

following apply (if it applies please tick the box)?

(a) the date of production or of import of the inspected

article is after the date of inclusion of the SVHC into the

Candidate List

The preconditions

for notification

are fulfilled in

case all three

boxes (a),(b) and

Pilot project on substances in articles – project report

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(b) the concentration of the selected CL substance is

> 0,1 % in the produced / imported articles

(c) the total amount of the selected CL substance, which is

present (>0,1 %) in the inspected and all other articles

produced or imported by the inspected company, exceeds the

limit of 1 t / year

 (d) no check for the preconditions was required (see

Question 28, lines a,b and c)

Note on option

(b): according to

the investigations

in questions 23

and 24

Note on option

(d): to be ticked

following the

conclusion

reached in

question 28, if

the inspector

starts with that

question (see

note under

question 26)

In case the selected CL substance has not been notified for

the inspected article(s) by the company, do the following

exemptions from the notification obligation apply for the

inspected article(s) (if it applies please tick the box)?

(a) Exposure to humans or the environment is

demonstrated to be excluded during normal or reasonably

foreseeable conditions of use of the inspected article,

including disposal.

(b) Substance is already registered for that use in the

inspected article

For the inspection

methodology see

the remark under

Question 27. An

exemption

applies if at least

one box (a), (b)

or (c) is ticked.

Art 7(3)

As it needs to be

ensured that the

CL substance

does not come

into contact with

humans or the

environment,

there is almost

never a reason

for an exemption

based on Art 7(3)

Art 7(6)

At a producer

(not assembler):

the use of the CL

substance in the

inspected article

should be

mentioned in the

Pilot project on substances in articles – project report

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(c) Six months after the date of inclusion of the SVHC in

the Candidate List have not yet passed in accordance with

Article 7(7) REACH

(d) no check for the exemptions was required (see

Question 27, lines a, b and c)

SDS (and in the

CSR) of the

registration of the

supplier of the CL

substance

At an importer:

as a minimum

the SDS or the

CSR of the CL

substance needs

to be available

for the importer

and they need to

cover the use of

the CL substance

in the inspected

article

Art 7(7)

Note on option

(d): to be ticked

following the

conclusion

reached in

question 27, if

the inspector

starts with that

question (see

note under

question 26)

In case the company had notified the selected CL substance

for the inspected article is the mandatory information

consistent with the inspected article:

(a) Is the annual tonnage band for the CL substance notified

to ECHA consistent with the data for relevant articles

produced / imported in the calendar year 2016

� Yes

� No

� Not checked

(bIs the brief general description of the identified uses of the

CL substance in the article (e.g. technical function) provided

in the notification consistent with the inspected article?

� Yes

� No

� Not checked

Please consider

for Question

28(c) for the

inspected article:

- “Article

Category”

according to

guidance R12

- overall

description of the

article

- user groups

- reasonably

foreseeable uses

/ misuses

Note for (a):

Article 7.4.f. of

Pilot project on substances in articles – project report

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in the notification consistent with the inspected article (article

service life)?

� Yes

� No

� Not checked

REACH

Note for (b) and

(c): Article 7.4.e.

of REACH

II. Communication obligation according to Article 33 REACH

Had the inspected company given the required information on

CL substance to the recipient of the article according to article

33 (1) REACH (B-to-B)

� Yes

� No

� Not relevant

� Other

This question is

related to the

communication

between the

inspected

company and its

commercial

customers/ the

recipients.

Has any consumer requested the information according to

article 33 (2)

� Yes

� No

� Other

If yes – had the required information on CL substance been

provided to the consumer within the 45 days?

� Yes

� No

� Not relevant

� other

If no - is the relevant information already available in the

inspected company?

� Yes

� No

� Not relevant

� other

This question is

related to the

communication

between the

inspected

company and its

customers/ the

recipients

(consumers).

Note: Article 36

documentation

duties apply for

the inspected

company

immediately

In case no

information is

already available

in the inspected

company the

company shall be

asked by the

inspector to make

the information

available from its

suppliers in order

to become

compliant with

Article 36

In case the

upstream supplier

of the inspected

company had not

Pilot project on substances in articles – project report

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provided the

article 33 (1)

information to the

inspected

company, the

upstream supplier

had potentially

not fulfilled his

duties according

to Article 33 (1).

In case of a communication obligation according to Article 33

(1) or Article 33 (2) exists what kind of information is / would

be provided?

� Information exists. Please specify:

 Name of the CL substance

 Specific article within a complex object containing CL

substances

 recipients are ONLY informed on CL substance at

the level of the complex object (not in-line with the

Court Decision)

 recipients are informed on CL substances at the

level of an article (in-line with the Court Decision)

 Information to allow safe use of the article (e.g. on

operational conditions / risk management measures for all

life cycle stages of the article, on user groups, information

that goes beyond the name of the CL substance)

 Give the text of the information:

 Concentration of CL substance (not mandatory to be

provided by the company))

� No information exists

� Not checked

� Not relevant

� Other, please specify:

Guidance cases

The decision of

the Court

emphasises the

requirement to

provide

information for

each article

within a complex

object. According

to the

interpretation of

the guidance the

communication

obligation could

only be given

ALSO on the level

of a complex

object in addition

to the

communication

obligation at the

level of an article.

(see Guidance

page 50ff)

This information

is not mandatory

but helpful for

further

assessment (e.g.

risk assessment,

exposure)

Did the NEA carry out own chemical analytics?

� Yes

� No

If yes, were the results in line with the information given by

the company?

� Yes

� No