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Andreas Hermann, Dirk Bunke (Öko-Institut)
1. 
Standardised communication format for articles Communication duties according to REACH Art. 33 
2. 
Information requirements for a registered use: Registration and notification obligations accord. to Art. 7 
3. 
Labelling obligations for articles containing SVHC
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 3
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 5 
 
No details within the legal text regarding the information which has to be exchanged 
 
„Minimal communication“, not sufficient to calculate the total amount, to ensure „safe use“ and to support substitution 
„Article contains DEHP“. 
„Article contains no Candidate Substances“ 
 
No information about exact content 
 
No advice on safe use
Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 6 
 Lack of administrative framework: in general no 
systematic gathering and analysis of 
information in purchased raw materials 
 Inadequate reliability of information 
 Standardised communication format only for 
substances and mixtures (Safety data sheet) 
 No standardised communication format for 
articles
 
Support for the exchange of sufficient information on SVHC 
 
No extension of duties, only specification 
 
Not comparable to safety data sheet for substances and mixtures, because less comprehensive 
 
Modular approach: add-on for existing systems 
 
for Art. 33.1 supply chain communication 
 
for Art. 33.2 communication to consumers, on request 
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 7
 
Information: SVHC yes / no 
 
Name + CAS-Number 
 
Hazard properties 
 
Concentration and Location 
 
Instructions for safe use 
 
Instructions for safe disposal Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 8
 
Template: contact Johanna Wurbs (johanna.wurbs@uba.de) 
http://www.umweltbundesamt.de/en/topics/economics- consumption/products/building-products/eu-law-for- construction-products/format-for-the-mandatory-designation-of 
 
UBA R&D Project, Supply chain communication on SVHC in articles, contact: Christopher Blum (christopher.blum@uba.de) http://svhc-in-articles- communication.de/index.php?id=web-tool 
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 9
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 10 
Example insulation board (EPS) with HBCDD
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 11 
Example insulation board (EPS) with HBCDD
Benefits 
Effective support of existing duties 
Standardisation of communication 
Integration into existing communication systems 
Support of faster response to information request 
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 12
 
Legal option: implement a new Annex XVIII 
 
Amendment covered by the current legal content of Art. 33 
 
Proposal already published! Available in E and DE 
 
Further option: requirement for suppliers to answer information request even if no SVHC present 
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 13
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 14
REACH Art. 7(1): Registration by producer of articles 
REACH Art. 7(2): Notification by producer of articles Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 15
 
Art. 7.3: No exposure? Supply appropriate instructions… 
 
…standardised information format could be used for this purpose! Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 16
REACH Art. 7(6): No duties – if already registered by producer of the substance! 
Clarification need: „..that have already been registered for that use….“ 
How to assess for the producer of the article? Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 17
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 18 
Same substance 
Type of article 
Quantity of SVHC contained 
Material specific migration and release rates 
Emission pattern over time 
Exposure potential
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 19 
 
Requirements to inform about the use of a substance: 
 
REACH Art. 10 (a) (iiii), r. Annex VI, section 3.5 
 
Technical dossier / 
 
chemical safety report section 2 
Only short description of the uses (UDS 
Detailed information: exposure scenarios, chemical safety report, section 9 
Communication of relevant information with extended safety data sheet (annexes or chapter 1- 16)
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 20 
 
State of the art: no detailed description of uses in articles 
 
Unsufficient information to decide whether use is registered or not , often only information from the Use Descriptor System 
 
Example Shampoo, plastic bottle, information needed: 
material of bottle 
amount of softeners in the material 
migration rate into shampoo 
exposure of consumers
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 21 
 
Specification of information in Annex VI and Annex I 
 
Clarification: following data have to be given and have to be communicated: 
Type of article 
Quantity of SVHC contained 
Material specific migration and release rates 
Emission pattern over time 
Exposure potential 
 
Priority item within dossier evaluation
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 22 
Benefits 
 
Improvement of exposure scenarios for substances used in articles (not only for SVHC) 
 
Improvement of protection of workers, consumers, envir 
 
Support of article producers to asses whether use has already been registered
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 23
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 24 
Background: 
 Present information duties (Art. 33 (2)) do not 
efficiently serve need for information of consumers. 
 No labelling requirements for SVHC in articles exist. 
Aim: 
 Information: SVHC is present in a concrete article. 
 Regarding parts/components for industrial users and 
final article for consumers. 
 Enable downstream users and consumers to avoid 
exposure with SVHC.
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 25 
Options to implement labelling duties: 
1) In existing product specific regulations: 
 No general product regulation 
 Which are the relevant product groups – regulatory 
gap? 
2) In CLP Regulation: 
 No general „SVHC“-label, but C&L criteria for CMR. 
 C&L for PBT and vPvB are so far not regulated and 
need international harmonisation.
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 26 
Options to implement labelling duties: 
3) In Art. 33 REACH: 
 Substances in articles on the interface of substance-regulation 
and product regulation. 
 REACH already contains regulation for SVHC in 
articles and criteria to identify PBT and vPvB. 
 Labelling is triggered by inclusion of SVHC on the 
Candidate List.
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 27 
Compatible with TBT: 
 A technical regulation (Art. 1.2/ Annex 1 No. 1 TBT). 
 Imported and domestic SVHC-products are like 
products. 
 Even if they are not like products, obligatory labelling 
does not violate Art. 2.1 TBT (MFN), because labelling 
applies equally.
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 28 
Compatible with TBT: 
 Not a unnecessary obstacle to international trade 
under Art. 2.2 TBT. 
 Serves the legitimate objective to „protect human 
health and the environment“ and is necessary to fulfill 
these objectives. 
 Art. 33 REACH is not equally suitable to inform 
recipients & consumers).
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 29 
Compatible with Freedom to conduct a business 
(Art. 16 CFR - Charter of Fundamental Rights of the EU): 
 Labelling as a description and presentation of 
products is an intervention (cf. ECJ C-306/93). 
 Justified by legitimate objectives „protection of 
environment“ and „health protection“ (cf. Art. 35 
CFR). 
 Less restrictive measure than a registry or ban for 
SVHC-articles and is not disproportionate.
Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 30
REACH Art. 7(1): Registration by producer of articles Stärkung der Regelungen für 
(Import-)Erzeugnisse in REACH 31

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Further options to improve information and communication on articles containing SVHC

  • 1. Andreas Hermann, Dirk Bunke (Öko-Institut)
  • 2. 1. Standardised communication format for articles Communication duties according to REACH Art. 33 2. Information requirements for a registered use: Registration and notification obligations accord. to Art. 7 3. Labelling obligations for articles containing SVHC
  • 3. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 3
  • 4. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 5  No details within the legal text regarding the information which has to be exchanged  „Minimal communication“, not sufficient to calculate the total amount, to ensure „safe use“ and to support substitution „Article contains DEHP“. „Article contains no Candidate Substances“  No information about exact content  No advice on safe use
  • 5. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 6  Lack of administrative framework: in general no systematic gathering and analysis of information in purchased raw materials  Inadequate reliability of information  Standardised communication format only for substances and mixtures (Safety data sheet)  No standardised communication format for articles
  • 6.  Support for the exchange of sufficient information on SVHC  No extension of duties, only specification  Not comparable to safety data sheet for substances and mixtures, because less comprehensive  Modular approach: add-on for existing systems  for Art. 33.1 supply chain communication  for Art. 33.2 communication to consumers, on request Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 7
  • 7.  Information: SVHC yes / no  Name + CAS-Number  Hazard properties  Concentration and Location  Instructions for safe use  Instructions for safe disposal Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 8
  • 8.  Template: contact Johanna Wurbs (johanna.wurbs@uba.de) http://www.umweltbundesamt.de/en/topics/economics- consumption/products/building-products/eu-law-for- construction-products/format-for-the-mandatory-designation-of  UBA R&D Project, Supply chain communication on SVHC in articles, contact: Christopher Blum (christopher.blum@uba.de) http://svhc-in-articles- communication.de/index.php?id=web-tool Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 9
  • 9. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 10 Example insulation board (EPS) with HBCDD
  • 10. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 11 Example insulation board (EPS) with HBCDD
  • 11. Benefits Effective support of existing duties Standardisation of communication Integration into existing communication systems Support of faster response to information request Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 12
  • 12.  Legal option: implement a new Annex XVIII  Amendment covered by the current legal content of Art. 33  Proposal already published! Available in E and DE  Further option: requirement for suppliers to answer information request even if no SVHC present Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 13
  • 13. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 14
  • 14. REACH Art. 7(1): Registration by producer of articles REACH Art. 7(2): Notification by producer of articles Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 15
  • 15.  Art. 7.3: No exposure? Supply appropriate instructions…  …standardised information format could be used for this purpose! Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 16
  • 16. REACH Art. 7(6): No duties – if already registered by producer of the substance! Clarification need: „..that have already been registered for that use….“ How to assess for the producer of the article? Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 17
  • 17. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 18 Same substance Type of article Quantity of SVHC contained Material specific migration and release rates Emission pattern over time Exposure potential
  • 18. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 19  Requirements to inform about the use of a substance:  REACH Art. 10 (a) (iiii), r. Annex VI, section 3.5  Technical dossier /  chemical safety report section 2 Only short description of the uses (UDS Detailed information: exposure scenarios, chemical safety report, section 9 Communication of relevant information with extended safety data sheet (annexes or chapter 1- 16)
  • 19. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 20  State of the art: no detailed description of uses in articles  Unsufficient information to decide whether use is registered or not , often only information from the Use Descriptor System  Example Shampoo, plastic bottle, information needed: material of bottle amount of softeners in the material migration rate into shampoo exposure of consumers
  • 20. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 21  Specification of information in Annex VI and Annex I  Clarification: following data have to be given and have to be communicated: Type of article Quantity of SVHC contained Material specific migration and release rates Emission pattern over time Exposure potential  Priority item within dossier evaluation
  • 21. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 22 Benefits  Improvement of exposure scenarios for substances used in articles (not only for SVHC)  Improvement of protection of workers, consumers, envir  Support of article producers to asses whether use has already been registered
  • 22. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 23
  • 23. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 24 Background:  Present information duties (Art. 33 (2)) do not efficiently serve need for information of consumers.  No labelling requirements for SVHC in articles exist. Aim:  Information: SVHC is present in a concrete article.  Regarding parts/components for industrial users and final article for consumers.  Enable downstream users and consumers to avoid exposure with SVHC.
  • 24. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 25 Options to implement labelling duties: 1) In existing product specific regulations:  No general product regulation  Which are the relevant product groups – regulatory gap? 2) In CLP Regulation:  No general „SVHC“-label, but C&L criteria for CMR.  C&L for PBT and vPvB are so far not regulated and need international harmonisation.
  • 25. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 26 Options to implement labelling duties: 3) In Art. 33 REACH:  Substances in articles on the interface of substance-regulation and product regulation.  REACH already contains regulation for SVHC in articles and criteria to identify PBT and vPvB.  Labelling is triggered by inclusion of SVHC on the Candidate List.
  • 26. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 27 Compatible with TBT:  A technical regulation (Art. 1.2/ Annex 1 No. 1 TBT).  Imported and domestic SVHC-products are like products.  Even if they are not like products, obligatory labelling does not violate Art. 2.1 TBT (MFN), because labelling applies equally.
  • 27. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 28 Compatible with TBT:  Not a unnecessary obstacle to international trade under Art. 2.2 TBT.  Serves the legitimate objective to „protect human health and the environment“ and is necessary to fulfill these objectives.  Art. 33 REACH is not equally suitable to inform recipients & consumers).
  • 28. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 29 Compatible with Freedom to conduct a business (Art. 16 CFR - Charter of Fundamental Rights of the EU):  Labelling as a description and presentation of products is an intervention (cf. ECJ C-306/93).  Justified by legitimate objectives „protection of environment“ and „health protection“ (cf. Art. 35 CFR).  Less restrictive measure than a registry or ban for SVHC-articles and is not disproportionate.
  • 29. Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 30
  • 30. REACH Art. 7(1): Registration by producer of articles Stärkung der Regelungen für (Import-)Erzeugnisse in REACH 31