1. Enforcement of SVHC Sibylle Wursthorn
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
Enforcement of SVHC
Sibylle Wursthorn
Ministry of the Environment, Climate protection and Energy Sector
Baden-Württemberg (Germany)
CLEPA Materials Regulations Event
Reutlingen,
Vortragender, Anlass,

2. Content
Titel des Vortrags
Legal basis
Guidance and ruling of the European Court of Justice
Enforcement of the REACH Regulation
Ruling of the European Court of Justice and enforcement
Requirements/ measures regarding compliance
Results from enforcement campaigns
Vortragender, Anlass,

3. Purpose of enforcement
Titel des Vortrags
important precondition for the functioning of the internal market of the EU
create confidence in the safety of chemicals placed on the market
ensure compliance with competitive conditions
ensure a level playing field for the economic operators
enhance protection of consumer, workers and the environment
Vortragender, Anlass,

4. Enforcement of chemicals legislation in Germany
Titel des Vortrags
Enforcement of chemicals legislation in Germany
enforcement is in the competence of the German Länder (states)
special organisation within the German Länder: competent jurisdiction ordinance in each of the German Länder
general regulation of enforcement: federal Chemicals Act
(a) coordination in Germany within a market surveillance programme
(b) coordination of the enforcement on the level of MS (e.g. REACH-EN-FORCE projects 1 – 5 of the Forum/ ECHA)
in Baden – Württemberg (one German Land) annual work program results published:
Vortragender, Anlass,

5. Legal basis SVHC (substances of very high concern)
Titel des Vortrags
Article 33 REACH regulation
Any supplier of an article containing a substance (…) in a concentration above 0,1 % weight by weight (w/w)
shall provide sufficient information, available to the supplier, to allow safe use of the article including
as a minimum, the name of that substance.
Article 33 (1): the recipient of the article
Article 33 (2): on request by a consumer within 45 days of receipt of the request.
Vortragender, Anlass,

6. Judgement of the European Court of Justice
Titel des Vortrags
Judgement of the European Court of Justice
In Case C‑106/14,
….it is for the supplier of a product one or more constituent articles of which contain(s) a substance of very high concern identified in accordance with Article 59(1) of that regulation in a concentration above 0.1% weight by weight of that article, to inform the recipient and, on request, the consumer, of the presence of that substance by providing them, as a minimum, with the name of the substance in question.
Vortragender, Anlass,

7. Titel des Vortrags
Perspective of an enforcement authority on the judgement of the European Court of Justice
ECJ emphasizes the active role all duty holders need to take in order to ensure their own compliance:
for compliance with Article 7(2) it is for the producers and importers to determine whether a SVHC is present in an article in a concentration above 0.1%
for compliance with Article 33 it is for the suppliers of an article with a SVHC present in a concentration above 0.1% to inform the recipients, as a minimum, with the substance name
 both REACH obligations require the duty holders to have knowledge about presence of SVHCs > 0,1% in articles
Vortragender, Anlass,

8. ECHA Guidance for substances in articles
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
ECHA Guidance for substances in articles
adaptation of ECHA Guidance for substances in articles at the ruling of the European Court of Justice
current state: draft to consultation in CARACAL (after different consultations)
Current version: Draft Version 4.0, April 2017
„Guidance on requirements for substances in articles“ (April 2017, Daft Version 4.0) – chapter information duties
“The substance concentration threshold of 0.1% (w/w) applies to every article supplied. This threshold applies to each article of an object made up of more than one article, which were joined or assembled together.” (chapter 3.2)
reference to „supplied article“
Vortragender, Anlass,

9. Compliance – Requirements (1)
Titel des Vortrags
supplier have to fulfil information duties in case an article contains SVHC above the threshold value,
information duty is triggered by the presence of the substance, does not depend on the knowledge of the supplier,
relevant for definition of compliance: correct information is passed on
„Guidance on requirements for substances in articles“ (April 2017, Draft Version 4.0)
“The communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances.” (chapter 3.2.1)
Vortragender, Anlass,

10. Compliance – Requirements (2)
Titel des Vortrags
enforcement authorities expect from the company substantive and documented evidence on presence/absence of SVHC in articles
in order to fulfil compliance : information (also lacking of information) from supplier
should be critically questioned
as a consequence of this: „an obligation to determine information“ could be derived
„an obligation to determine information“ could be: contractual arrangement, request by the supplier …
„Guidance on requirements for substances in articles“ (April 2017, Draft Version 4.0)
“The communication obligations arise from the presence of the Candidate List substance in the article. These obligations apply regardless of whether or not the supplier is aware of the presence of the substances. Therefore, it is in the interests of the supplier to seek information on the presence of Candidate List substances.” (chapter 3.2.1)
Vortragender, Anlass,

11. Compliance – Requirements (2)
Titel des Vortrags
„Guidance on requirements for substances in articles“ (April 2017, Draft Version 4.0)
“Where the information received or available is not sufficient to check compliance and comply with REACH, producers, importers and other suppliers of articles should consider obtaining the necessary information by pro-active requests in the supply chain.” (chapter 5.1.3)
“The confirmation of the presence of Candidate List substances in the articles could be done by requesting information up in the supply chain and evaluating the information provided by suppliers…” (Appendix 5)
Vortragender, Anlass,

12. sanctioning measures
Titel des Vortrags
sanctioning measures as an instrument to demand compliance (e.g. in cases of continuous non-compliances sanctioning measures can be repeated / increased)
active efforts of the supplier relevant e.g. for pursuing non-compliance with a fine
in case of sanctioning measures enforcement authorities consider e.g.:
accusation/ (gravity of) culpability / the endeavour for compliance of the company
reach /relevance/ consequences/ severity of the non-compliance
in DE: any non-compliance with Article 33 of REACH can be imposed with a fine:
in case of intentional breach or gross negligence
provide information not, not correctly, not completely, not in the described manner or not on time,
=> fine up to €
Vortragender, Anlass,

13. Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
administrative discretion of the authority – compliance „efforts“ of the supplier
description of compliance procedures / related considerations within the company
examples
Application of a systemic effort/ approach
knowledge regarding SVHC in articles/ materials
SVHC related content in contracts with suppliers
systematic enquiries on SVHC at the suppliers (priority-setting / plausibility checks for answers)
purchase: enquiry on SVHC
in cases with justified doubts: analytical (confirmatory) test
Vortragender, Anlass,

14. concept „complex object“
Titel des Vortrags
„complex product“: in judgement of ECJ
In „Guidance on requirements for substances in articles“ (April 2017, Draft Version 4.0): „complex object “
mixture M, e.g. adhesive, solder)
supplier of an article, information to:
the Candidate List substance X in article A
the Candidate List substance Y in article B
the Candidate List substance Z in complex object D
Vortragender, Anlass,

15. Enforcement
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
legal interpretation of ECJ is enforced in individual cases and in enforcement campaigns
ECHA-Forum: pilot project in 2017
Experiences of enforcement campaigns in BW: high incompliance rates
Vortragender, Anlass,

16. Enforcement campaign in Baden-Württemberg
Titel des Vortrags
SVHC in the focus of the campaign
phthalates
Bis (2-ethylhexyl)phthalate (DEHP)
Dibutyl phthalate (DBP)
Benzyl butyl phthalate (BBP)
Diisobutyl phthalate (DIBP)
Diisoheptyl phthalate (DIHP)
Bis(2-methoxyethyl) phthalate (BMEP)
N-Pentyl-isopentylphthalate (PIPP)
Dipentyl phthalate (DPP)
Diisopentyl phthalate (DIPP)
Dihexyl phthalate (DHP)
flame retardants
Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
Hexabromocyclododecane (HBCDD), identified isomers
Tris(2-chloroethyl)phosphate
Vortragender, Anlass,

17. Inspection procedure sampling in retail business/ on the market
Titel des Vortrags
sampling in retail business/ on the market
retailers are requested to provide information on the presence of SVHC in concentration > 0,1 % in articles
sampling of the articles from the market
analysis of the articles regarding the SVHC concentrations
inspection of duty holder’s “compliance system”
inspection of the system with a questionnaire
request for information on specific articles
active request for information on specific articles at the supplier
sampling of articles received
analysis of samples regarding SVHC concentrations
Vortragender, Anlass,

18. incorrect SVHC information of companies when compared with authority’s chemical analysis
Titel des Vortrags
not analysed 11 %
„non-compliance rate“ - constantly high ca. 30 %
34 % incorrect
55 % correct
Vortragender, Anlass,

19. Evaluation of inspected articles information of companies compared to results of chemical analysis -
Titel des Vortrags
427 products
thereof threshold value in articles exceeded:
e.g.
97 x DEHP
2 x BBP
14 x DIBP
1 x DBP
112 articles with SVHC exceeding threshold value
315 articles without SVHC or SVHC below threshold value
Vortragender, Anlass,

20. - examples rubber/plastic boots/shoes -
Titel des Vortrags
DEHP: 12% bzw. 28%
also with non-SVHC „substitutes“
DEHP > 5%
DINP 0,9%
DEHP > 1%
DEHT > 1%
DEHT > 5%
Vortragender, Anlass,

21. - example sink inlays - 2 different phthalates DEHP 18 % BBP 0,2%
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
2 different phthalates
DEHP 18 % BBP 0,2%
also with non-SVHC „substitutes“
DIBP > 5%
DEHP 0,3%
DEHT 0,6%
DINP 0,5%
DIDP 0,3%
DEHT > 5%
DPDP 0,5%
Vortragender, Anlass,

22. Experiences - SVHC
Titel des Vortrags
knowledge on SVHC duties in companies is different: - some companies are well prepared, - others: serious need for more attention on SVHC and for advice
challenges in implementation:
SVHCs are not a priority for companies
SVHC requirements are not understood, lack of knowledge
needs for compliance improvement: more active role of all suppliers in the supply chain (in line with ECJ ruling): - active communication within the supply chain (up and down) - assessment of information received (plausibility check)
„knowledge“ of substances within the context of restriction not/ less discussed
Vortragender, Anlass,

23. Summary presence of SVHCs trigger the information duties
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
presence of SVHCs trigger the information duties
responsibility regarding the information duty is up and down the supply chain („obligation to determine information“) and includes an “active role”
compliance „efforts“ (i.e. effort to fulfil „obligation to determine information“) will always be part of the assessment of the sanctioning measures
REACH‘s concept for an informed supply chain is clearly hampered by a far too low compliance rate for SVHC communication duties
Vortragender, Anlass,

24. Thank you! Sibylle Wursthorn
Titel des Vortrags (Menü Ansicht / Kopf- und Fußzeile / Notizblätter und Handzettel)
Thank you!
Sibylle Wursthorn
Ministry of the Environment, Climate protection and Energy Sector
Baden-Württemberg (Germany)
Tel: /
Vortragender, Anlass,

25. Enforcement: legal basis
Titel des Vortrags
REACH Regulation
Article 125: System of official controls in MSs
Article 126: rules on penalties in MSs
national legislation
Chemicals Act:
competence and powers of competent national enforcement authorities (e.g. order issuing competence)
provisions on penalties :
administrative fine
criminal offence
Vortragender, Anlass,

26. Joint enforcement REACH / POP regulation: short chain chlorinated paraffins (SCCP) in articles
Titel des Vortrags
below the limit of quantification
or ≤ 0,1% (80 material samples, 50 products)
85 products
> 0,1% and < 0,15%
(0 material samples,
0 products)
≥ 0,15%
(47 material samples,
20 products)
examples:
plastic components of electric products
concentration: up to 8 %
Vortragender, Anlass,

27. Enforcement case (1) - situation
Titel des Vortrags
Company A has purchased article in EU
company A without contract with EU-supplier on SVHC communication
supplier does not provide information on SVHC
inspection of the authority (including laboratory tests)
company A declares: article is without SVHC
results of the chemical analysis: SVHC (DEHP) > 0,1%
Vortragender, Anlass,

28. Case (1) – enforcement procedure
Titel des Vortrags
non-compliance with Article 33 of the REACH Regulation
corrective measures: evidence on an established compliance procedure that guarantees full observation of information duties in the future
fine (if necessary) – administrative discretion of the authority => consideration of the compliance „efforts“
information to the enforcement authority competent for the supplier (as supplier is also non-compliant – supplier’s non-compliance also verified)
imposing refund of testing costs
Vortragender, Anlass,

29. Enforcement case (2) - situation
Titel des Vortrags
Company A has purchased article outside of EU
company A has a contract with non EU-suppliers on SVHC communication
for a relevant number of articles: analytical tests on SVHC
also enquiries on presence of SVHC at the non-EU supplier
for one article: supplier does not provide information on SVHC
inspection of the authority (including laboratory tests)
company A declares: article is without SVHC
result of the chemical analysis: DEHP > 0,1%
Vortragender, Anlass,

30. Case (2) – enforcement procedure
Titel des Vortrags
non-compliance with Article 33 of the REACH Regulation
corrective measures: evidence on an established compliance procedure that guarantees full observation of information duties in the future
fine (if necessary) – administrative discretion of the authority
imposing refund of testing costs
Vortragender, Anlass,