1. Biocides Dissemination
High-level planning
Biocides CA Meeting
Chiara Macchi and Catherine Cornu
Dossier Submission and Dissemination Unit
INTERNAL
1/3/2019

2. Topics for discussion Similarities between the BPR and REACH
ECHA’s approach to Dissemination under REACH
Dissemination under the BPR
Dissemination of “historical data” (submitted under the BPD)
Active Substance (AS) dossiers
Biocidal Product (BP) dossiers
Dissemination of new dossiers (submitted under the BPR)
INTERNAL
1/3/2019

3. Similarities between REACH and the BPR
INTERNAL
1/3/2019

4. Info that MUST be disseminated - AS
REACH Art. 119(1)
IUPAC name (dangerous substances)
EINECS name
C&L
Phys-chem data concerning the substances & on pathways and environmental fate
Result of each toxicological & ecotoxicological study
DNELs or PNECs
Guidance on safe use
Analytical methods
BPR Art. 67(1)
ISO name / IUPAC name
EINECS name
C&L
Phys-chem endpoints & data on pathways, environmental fate and behaviour
Result of each toxicological & ecotoxicological study
Accepted exposure level & PNEC
Guidance on safe use
Analytical methods
INTERNAL
1/3/2019

5. Info that must be disseminated – in detail
Article 119
Electronic public access
1. The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
(a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 [...]
(b) if applicable, the name of the substance as given in EINECS;
(c) the classification and labelling of the substance;
(d) physicochemical data concerning the substance and on pathways and environmental fate;
(e) the result of each toxicological and ecotoxicological study;
(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
(g) the guidance on safe use provided in accordance with sections 4 and 5 of Annex VI;
(h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.
Article 67
Electronic public access
1. From the date on which an active substance is approved, the following up-to-date information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge:
(a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
(b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
(c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
(d) physicochemical endpoints and data on pathways and environmental fate and behaviour;
(e) the result of each toxicological and ecotoxicological study;
(f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
(g) the guidance on safe use provided in accordance with Annexes II and III;
(h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
INTERNAL
1/3/2019

6. Info that can be claimed confidential - AS
REACH Art. 119(2)
Degree of purity (if essential to the C&L)
The total tonnage band within which the substance was registered
The SS or RSS
Other info contained in the SDS
The trade name of the substance
The IUPAC name under particular circumstances
BPR Art. 67(3)
Degree of purity (if essential to the C&L) -
The SS or RSS of studies submitted to support the AS approval
Other info contained in the SDS
The trade name(s) of the substance
The assessment report
INTERNAL
1/3/2019

7. Info that can be claimed confidential – in detail
2. The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:
(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
(b) the total tonnage band (i.e tonnes, tonnes, tonnes or over tonnes) within which a particular substance has been registered;
(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
(d) information, other than that listed in paragraph 1, contained in the safety data sheet;
(e) the trade name(s) of the substance;
(f) [...]
(g) [...]
3. From the date on which an active substance is approved, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on active substances:
(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
(b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
(c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
(d) the trade name(s) of the substance;
(e) the assessment report.
INTERNAL
1/3/2019

8. ECHA’s approach to Dissemination under REACH
INTERNAL
1/3/2019

9. Dissemination of registrations in ECHA
Dissemination project started in
From number of registrations expected  automated dissemination needed
Development of systems
Determining in collaboration with the stakeholders which information from the dossier is disseminated, based on article 119 of REACH
Launch of the dissemination portal in December 2009
System upgrades since then
Portal has been populated and now contains
Data on 7663 substances from registrations submitted to ECHA
More than 1.5 million study summaries on properties and effects of chemicals
INTERNAL
1/3/2019

10. How does ECHA disseminate registrations1
Registration is complete
Registration dossier is scheduled for dissemination
Registration dossier is “filtered” = only information listed in article 119 is left in the dossier 2 3 4 5
INTERNAL
1/3/2019

11. Filtering with the filter tool
Setting for every field in a IUCLID 5 registration dossier:
Always published e.g. EINECS name, C&L, results of tox and ecotox studies, …
Never published e.g. production process, estimated tonnage, file modification history, …
Published unless claimed confidential e.g. trade name, study summaries, …
Potentially published published depending on other content in the dossier, e.g. author is published for review article but not for study report, impurities are published if they are indicated as essential to the C&L, unless they are claimed confidential, …
INTERNAL
1/3/2019

12. How does ECHA disseminate registrations1
Registration is complete
Registration dossier is scheduled for dissemination
Registration dossier is filtered = only information listed in article 119 is left in the dossier
For joint submissions: filtered dossiers are aggregated = the information on the substance from all dossiers in the joint submission are merged into one dossier
Dossier is disseminated on ECHA website 2 3 4 5
INTERNAL
1/3/2019

13. How did the filter rules come to be?
In collaboration with ECHA experts and stakeholders
6 July 2009: round table discussion with stakeholders
22 participants from industry, NGOs, trade unions, OECD, COM, EP
Agreement on the principles of dissemination
Filter rules determined after a subsequent written consultation period
Updates needed when the IUCLID format is extended
e.g. results of the PBT / vPvB assessment
INTERNAL
1/3/2019

14. Tools for registrants IUCLID dissemination plugin
Before submitting the dossier, registrants can use the plugin to simulate which information from their dossier will be disseminated by ECHA
Manual on Dissemination (DSM 15)
Explains the principles and practicalities of dissemination
Has 6 technical annexes with screenshots of the entire IUCLID dossier. For each field, an icon shows if the content of the field will/will not be disseminated
INTERNAL
1/3/2019

15. Synergies Dissemination is based on the IUCLID format
IUCLID is a data repository. Registrants have the biocides data and the REACH data (on the same substance) in the same system  different approaches for dissemination of registrations and biocides dossiers would be impractical for the registrants
For many items, the REACH text and the BPR text (AS) are
identical: 1(b), 1(e), 3(c), 3(d)
conceptually the same: 1(d), 1(g), 3(a), 3(b), 4(a)
same, but with an additional element: 1(a), 1(c), 1(f), 1(h), 2(c)
entirely new: 2(a), 2(b), 3(e), 4(b)
INTERNAL
1/3/2019

16. Electronic public access Electronic public access
Synergies
Article 119
Electronic public access
1. The following information held by the Agency on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e):
(a) without prejudice to paragraph 2(f) and (g) of this Article, the name in the IUPAC nomenclature for substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/2008 [...]
(b) if applicable, the name of the substance as given in EINECS;
(c) the classification and labelling of the substance;
(d) physicochemical data concerning the substance and on pathways and environmental fate;
(e) the result of each toxicological and ecotoxicological study;
(f) any derived no-effect level (DNEL) or predicted no-effect concentration (PNEC) established in accordance with Annex I;
(g) the guidance on safe use provided in accordance with sections 4 and 5 of Annex VI;
(h) analytical methods if requested in accordance with Annexes IX or X which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans.
Article 67
Electronic public access
1. From the date on which an active substance is approved, the following up-to-date information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge:
(a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
(b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
(c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
(d) physicochemical endpoints and data on pathways and environmental fate and behaviour;
(e) the result of each toxicological and ecotoxicological study;
(f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
(g) the guidance on safe use provided in accordance with Annexes II and III;
(h) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
INTERNAL
1/3/2019

17. Synergies
2. The following information on substances whether on their own, in preparations or in articles, shall be made publicly available, free of charge, over the Internet in accordance with Article 77(2)(e) except where a party submitting the information submits a justification in accordance with Article 10(a)(xi), accepted as valid by the Agency, as to why such publication is potentially harmful for the commercial interests of the registrant or any other party concerned:
(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
(b) the total tonnage band (i.e tonnes, tonnes, tonnes or over tonnes) within which a particular substance has been registered;
(c) the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
(d) information, other than that listed in paragraph 1, contained in the safety data sheet;
(e) the trade name(s) of the substance;
(f) [...]
(g) [...]
3. From the date on which an active substance is approved, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to-date information on active substances:
(a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
(b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
(c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
(d) the trade name(s) of the substance;
(e) the assessment report.
INTERNAL
1/3/2019

18. Synergies
The information on BPs cannot be compared to REACH but it is conceptually the same as the information for AS.
2. From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information:
(a) the terms and conditions of the authorisation;
(b) the summary of the biocidal product characteristics; and
(c) analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
4. From the date on which a biocidal product is authorised, the Agency shall, except where the data supplier submits a justification in accordance with Article 66(4) accepted as valid by the competent authority or the Agency as to why such publication is potentially harmful for its commercial interests or any other party concerned, make publicly available, free of charge, the following up-to date information:
(a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
(b) the assessment report.
INTERNAL
1/3/2019

19. Proposal for agreement
Considering that
The data format for biocides dossier and REACH registrations is the same IUCLID format;
Stakeholders have been involved in establishing the filter rules and a balanced package was achieved;
The legal requirements on ECHA for the dissemination of biocides dossiers and of REACH registrations are the same for many items
It is proposed that the filter rules under REACH will also apply for the biocides dossiers for those items where the legal requirements are the same
For the additional and new elements, filter rules will need to be discussed (Q4 2012)
Also for the additional (robust) study summaries to be submitted under the BPR (in IUCLID sections 9 and 10), filter rules will need to be discussed (Q4 2012)
INTERNAL
1/3/2019

20. Why start with this now? Lessons learned from REACH dissemination:
How information is disseminated determines to some degree how the information is entered in the dossier
To avoid that registrants have to screen entire dossiers and re-enter information, the knowledge of how information is disseminated needs to be available (well) before dossiers need to be submitted
Since dossiers can be submitted as of 1 September 2013
 dissemination tools / manuals need to be ready by end of June 2013
 efficiency gains by re-using tools and processes from REACH is essential
 preparations / discussions need to start now
INTERNAL
1/3/2019

21. Dissemination of historical data - AS
INTERNAL
1/3/2019

22. Background info on “historical data” on AS
Submitted to the JRC under the BPD – i.e. before
(→ the JRC has all the dossiers)
To be disseminated by ECHA as from the date of approval - i.e. as of
On ~ AS dossiers will be approved
All dossiers were submitted as doc files and some also have a IUCLID file attached
As not all dossiers have a IUCLID file and those which do probably require migration to the latest version, ECHA will not publish the IUCLID data sets but standardise and disseminate extracts from the documents in all cases.
The ARs for AS are currently publicly available documents (accessible via CIRCABC which anyone can access)
DOC III is currently not a publicly available document
INTERNAL
1/3/2019

23. Dissemination of AS dossiers (overview)
Art. 67(1) From the date of approval ECHA MUST disseminate:
a) where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
b) if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
c) the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
d) physicochemical endpoints and data on pathways and environmental fate and behaviour;
f) acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
All of the above can be found in the Assessment Report (AR)
INTERNAL
1/3/2019

24. Dissemination of AS dossiers (overview)
Art. 67(1) From the date of approval ECHA MUST disseminate:
e) the result of each toxicological and ecotoxicological study;
 a short summary of the key studies can be found in the AR
g) the guidance on safe use provided in accordance with Annex II and Annex III;
 DOC IIIA
h) analytical methods referred to under sections 5.2 and 5.3 of Title 1, and section 4.2 of Title 2 of Annex II.
INTERNAL
1/3/2019

25. Dissemination of AS dossiers (overview)
Art. 67(3) ECHA will disseminate unless claimed confidential:
a) if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
d) the trade name(s) of the substance;
e) the assessment report
All of the above can be found in the Assessment Report (AR)
INTERNAL
1/3/2019

26. Dissemination of AS dossiers (overview)
Art. 67(3) ECHA will disseminate unless claimed confidential:
b) the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
 DOC III A&B (currently confidential)
c) information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
 from a preliminary check it seems that there is no additional information (that is not covered by another provision in this Article)
Company name
Approval/Authorisation number
PBT assessment
Uses
INTERNAL
1/3/2019

27. Dissemination of AS dossiers - proposal
No problem for the items included in the AR
(e) ECHA publishes only the summaries of the results of key studies
Identification of those sections in DOC III which are not confidential and correspond to points
(g) guidance on safe use
(h) analytical methods
Extraction of the above-mentioned sections and subsequent publication as pdf files
Most “interesting” information is in the SS and RSS which are in DOC III A+B
In order to disseminate them ECHA must contact industry and request a non-confidential version of selected elements of their DOC IIIs (to be submitted by )
INTERNAL
1/3/2019

28. Dissemination of historical data - BP
INTERNAL
1/3/2019

29. Background info on “historical data” on BP
Submitted to the MS under the BPD – i.e. before
To be disseminated by ECHA as from the date of authorisation - i.e. as of
On ~ 2000 BP dossiers will be authorised
Not all submissions are associated to a IUCLID file
DG ENV/JRC do not have copies of these dossiers
Info on BP dossiers is currently not publicly available
Some SPCs are available in R4BP but not all of them
All BP dossiers are subject to renewal (starting in 2017)
INTERNAL
1/3/2019

30. Dissemination of BP dossiers (overview)
Art. 67(2) From the date of authorisation ECHA MUST disseminate:
a) the terms and conditions of the authorisation;
b) the summary of the biocidal product characteristics (SPC);
c) analytical methods referred to under sections 5.2 and 5.3 of Title 1, and section 5.2 of Title 2 of Annex III.
Art. 67(4) ECHA will disseminate unless claimed confidential:
a) study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation;
b) the assessment report.
INTERNAL
1/3/2019

31. Dissemination of BP dossiers - proposal
ECHA will disseminate what can be extracted from R4BP
As from September (with the new R4BP release) MS will be asked to systematically upload all the new SPCs
MS will receive a communication informing them that they should update R4BP with the old SPCs so that ECHA can disseminate them
Some SPCs may contain confidential information that would need to be removed prior to uploading to R4BP in order for ECHA to disseminate the remaining parts
INTERNAL
1/3/2019

32. Dissemination of new dossiers

33. Background info on “New Dossiers”
Submitted directly to ECHA via R4BP after EiO of the BPR – i.e. after
All dossiers will be submitted using the latest version of IUCLID
They will not be disseminated after submission but after evaluation + committees + publication in OJ
first dissemination ~ in Q2/Q3 2015
Estimated volumes:
AS ~ 5/year
BP ~ /year
INTERNAL
1/3/2019

34. Roadmap for dissemination of new dossiers (1)
2012
Q3 Finalising the technical details for IUCLID 5.5
Q3/Q4 Discuss the overall strategy for dissemination with CAs
Q4 Release IUCLID 5.5 with the plug-in for creating biocides dossiers
2013
Q1 Consultation with stakeholders on filter rules and subsequent modification
Q1 Adapt the existing IUCLID dissemination plug-in for processing biocides dossiers
Q2 Modify and release existing ECHA manuals
Q2 Release the IUCLID dissemination plug-in
1 September: go-live of dissemination website with the biocides historical data
INTERNAL
1/3/2019

35. Roadmap for dissemination of new dossiers (2)
2014
Adapt the dissemination pipeline
Go-live of IUCLID 6
2015
Q2/Q3 Dissemination of biocides dossiers submitted under the BPR
INTERNAL
1/3/2019

36. Actions requested from MSCAs
Dissemination of historical AS dossiers: in the absence of information in a structured (IUCLID) format, ECHA will satisfy its dissemination obligations by disseminating the Assessment Reports and selected elements of DOC III A+B (non-confidential version to be prepared by industry by )
 MSCAs to provide comments in writing (if any)
Dissemination of historical BP dossiers: ECHA will disseminate what can be extracted from R4BP
 MSCAs to upload the old SPCs in R4BP as soon as possible, and at the latest by April 2013 (taking into account that some SPCs may contain confidential information that would need to be removed prior to uploading)
Dissemination of dossiers submitted under BPR: ECHA proposes to use REACH as a starting point and proposes that the filter rules under REACH will also apply for the biocides dossiers for those items where the legal requirements are the same
INTERNAL
1/3/2019

37. Thank you
Chiara Macchi and Catherine Cornu