Comments on ECHA’s Draft 11th Recommendation for glutaral (EC number: 203-856-5) and references to responses

The present document compiles the comments received during the consultation on the draft 11th recommendation for inclusion of substances in Annex XIV of REACH for glutaral (EC number: 203-856-5). The consultation took place between 2 February 2022 and 2 May 2022.

For each of the comments there is also a reference to specific section(s) of a document containing the responses to comments (“Response document”, available at the substance specific entry of the list of Recommendations for inclusion in the Authorisation List (https://echa.europa.eu/recommendations-for-inclusion-in-the-authorisation-list). The responses in the Response document are arranged by thematic block and level of information (see more detailed explanations at the beginning of that document).

PUBLIC

Content
	
I - General comments on the recommendation to include the substance in Annex XIV
II - Transitional arrangements. Comments on the proposed dates
III - Comments on uses that should be exempted from authorisation, including reasons for that

I - General comments on the recommendation to include the substance in Annex XIV

Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3687
2022/04/22	Individual,
France	Diagnostica Stago wishes to comment on public consultation related to Glutaral - see confidential document attached.	A.1.1.5. New information and next steps towards the final recommendation
B.1.1.2. ECHA's proposal for sunset dates
B.1.1.3. ECHA's proposal for latest application dates
B.2.01 request a LAD 24 months
C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01 Exemption for research and development, medical sector, medical devices	
		
Confidential attachment removed
		
4137
2022/04/29	BASF SE,
Company,
Germany	Please see the attached document for BASF SE's comments.	A.1.1.5. New information and next steps towards the final recommendation
A.1.2.1. Volume in the scope of authorisation
A.2.01 Claiming uses in leather tanning and as cross-linking agent as intermediate
A.2.02 Questioning the volume score assigned
A.2.03 Questioning the WDU assessment	
		4137_111-30-8 GA Comments of the Lead registrant BASF SE to annex XIV prioritisation 20220429f.pdf
		
4186
2022/04/29	Follmann-Chemie Gmbh & Co.KG,
Company,
Germany	Gerne beteiligen wir uns an der Konsultation zur Aufnahme von Glutaral in den Anhang XIV und kommentieren dies wie folgt:
Glutaral wird bei uns unter industriellen Produktionsbedingungen als Crosslinker bzw. als Intermediate zur Bildung eines Crosslinkers (Kondensationsreaktion) in einem Koazervationsverfahren zur Herstellung von biologisch abbaubaren Mikrokapselsystemen verwendet. Die Anwendung findet in der Regel im geschlossenen System oder unter Verwendung der persönlichen Schutzausrüstung (Atemschutzmaske, Handschuhe, Schutzbrille), sowie unter technischer Absaugung statt. Die in Deutschland geltenden Arbeitsschutzregelungen geben alle notwendigen Vorgaben, um einen Stoff sicher zu überwachen und somit anzuwenden (sz-bitte Rü im Jour fixe) . Dies zeigen auch die regelmäßig durchgeführten Arbeitsplatzgrenzwertmessungen in unserer Produktion.
Wir sehen die Zulassung von Glutaral im Rahmen der SVHC Stoffbewertung in der Verwendung als Crosslinker als nicht zielführend an. Crosslinker finden in der Regel in industriellen Produktionsanlagen Anwendung. Sie gehen in der Reaktion auf und sind sicher in einer Konzentration unter 0,1 % im daraus entstehenden Produkt enthalten.
Der enthaltene Restmonomergehalt nach der chemischen Reaktion (kleiner 50ppm) führt derzeit gemäß der gültigen Regularien in der CLP-VO zu keiner Gefahreneinstufung. Es wird also davon ausgegangen, dass der Restmonomergehalt nicht zu den Eigenschaften der Hautreizung oder Atemwegssensibilisierung wie der Reinstoff beiträgt. Es liegen n.u.K. derzeit keine Erfahrungen aus der täglichen Anwendung solcher Produkte vor, die auf gesundheitsschädliche Wirkungen hinweisen. Ggf. wäre es zur Klärung dieser Fragen sinnvoll gezielte Untersuchungen/Analysen durchzuführen, um die Vorgaben der Kennzeichnung gemäß CLP sicher zu bestätigen.
Mit REACh wird der risikobasierte Ansatz in der Verwendung verfolgt. Dies sollte auch bei Stoffen zur Anwendung kommen, die SVHC Kriterien erfüllen. Daher sollte die gefährliche Einstufung eines Stoffes alleine nicht der Grund sein, diesen für die Verwendung im industriellen Maßstab zu verbieten, sondern Entscheidungen immer mit einer Risikoabschätzung einhergehen.	A.2.01 Claiming uses in leather tanning and as cross-linking agent as intermediate	
		
Confidential attachment removed
		
4236
2022/04/29	German Association of the Automotive Industry (VDA),
Industry or trade association,
Germany		A.2.04 Presence as substance in articles is negligible	
		
Confidential attachment removed
		
4265
2022/04/29	TFL Ledertechnik GmbH,
Company,
Germany	Please refer to details given in the attachment	A.1.1.5. New information and next steps towards the final recommendation
A.1.5.6. Socio-economic benefits of continued use
A.2.04 Presence as substance in articles is negligible	
		4265_Glut Auth Comments SUBMISSION.pdf
		
4279
2022/04/29	MedTech Europe,
Industry or trade association,
Belgium	Please refer to the attached submission.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01 Exemption for research and development, medical sector, medical devices	
		4279_MedTech Europe submission glutaral REACH Annex XIV.pdf
		
4674
2022/05/01	Microbial Control (Netherlands) B.V.,
Company,
Netherlands	Please, refer to our comments attached in Section V.	A.1.1.5. New information and next steps towards the final recommendation
A.1.2.1. Volume in the scope of authorisation	
		4674_GA as intermediate Leather_MC-NL.pdf

Confidential attachment removed
		
4794
2022/05/02	Nordic Leather Research Council,
Industry or trade association,
Sweden	The Nordic Leather Research Council representing all tanneries in Sweden, Denmark, Finland and Norway recognizes the initiatives and efforts taken by the Swedish Chemical Agency and ECHA to regulate glutaraldehyde in order to protect the health of consumers and workers.
The Nordic Leather Industry strongly believe that the proposal by ECHA to include glutaral in the Authorization List (REACH) is the not the correct instrument to achieve any positive health or environmental effects.
Our opinion is that any new chemical legislation clearly should lead to positive effects on the health for consumers/workers and/or lead to environmental benefits.
The main potential risk with glutaral in connection with leather tanning is according to our opinion if glutaral would still be present in leather articles in concentrations that could provoke allergy. It would be a potential health risk for consumers and workers in the leather utilizing industries. This potential problem is already addressed by a restriction proposal on skin sensitizers in leather made by Sweden and France (“restriction proposal on the placing on the market of textile, leather, hide and fur articles containing skin sensitizing substances”). One positive aspect of the Swedish and French restriction proposal is that it would cover all leather articles on the market in the EU including imported leather products. Most of the leather on the EU market are produced outside the EU. This restriction proposal would clearly offer a protection for consumers taking into consideration the classification of glutaral as skin sens. Cat 1A. Therefore, the inclusion of glutaral in Annex XIV (Authorisation List) would not have any effect in relation to the protection of consumers since this already is covered by other legislation.
Glutaral is also characterized as a respiratory Sensitiser cat.1. This could potentially be a health problem for workers provided the actual use of glutaral in tanneries would not be safe. However, it is the clear opinion of the Nordic Leather Research Council that the use of glutaral in tanneries in the EU is safe. There are currently three tanneries in the Nordic countries using glutaral in the production of leather (the leather industry in the Nordic countries is small). All tanneries in the Nordic countries are using a chemically modified form of glutaraldehyde which releases the chemical gradually during the tanning process. As a result of this, the concentration of glutaraldehyde in the process water will be kept low reducing the risk that glutaraldehyde will be emitted to the atmosphere in concentrations that could possess a health risk for the workers in the tannery.
It is also our understanding that chemically modified glutaral in general is used by the tanneries in Europe. This statement cannot be made for tanneries outside the EU (it is possible to use non-modified glutaraldehyde in the process). We therefore do not believe that the proposal could be justified by any potential health risks for workers in the EU.
The third potential risk is the potential risk to the environment.  However, the EU BREF Document for the Tanning of Hides and Skins states the following “Glutaraldehyde is generally fully exhausted in the tanning process. Any residual glutaraldehyde that may reach the waste water treatment plant will react quickly with the proteins from other effluent streams and generally does not pose a problem in effluent treatment”.
Therefore, our opinion is that the proposal to include glutaraldehyde on the Authorisation List cannot be justified by environmental reasons.
Additionally, one important aspect is whether alternatives to glutaral are available and the potential consequences of the proposed legislation. The Nordic Research Council is aware that ECHA normally does not consider the availability and suitability of alternatives when prioritizing substances for the introduction into the Authorization List. Nevertheless, we will provide some relevant information relating to expected scenarios if glutaral will be included in the authorization list (since no realistic alternatives to glutaral exist).
The background document correctly state that glutaral is the most common alternative to chromium-based tanning for a range of types of leather. One possible effect of the proposal from ECHA would be that tanneries increase the use of chromium as a tanning agent in the future. It is our opinion that tanning with chromium is a safe method provided it is carried out properly. However, we are very surprised that ECHA is proposing legislation that actually in practice would encourage chrome tanning instead of alternatives to chromium tanning. Even if we understand that this is not the justification for the proposal from ECHA, it may be interpreted this way by stakeholders including press and NGOs.
We believe that a substantial part of the chromium-free production of leather in the EU will be moved outside the EU to countries with less stringent chemical control. It is very common that parts of the leather processes are done in other tanneries in multiple countries so logistically it will be no problem. If our concerns will come true, the actual result of the proposed legislation would be that this part of the production will take place outside the EU in countries with less strict chemical legislation. Therefore, the protection of workers worldwide may actually be reduced and from our point of view this is not the objective of European Chemical legislation.     ‘

	A.1.5.1. Potential other regulatory actions
A.1.5.4. Control of risks
A.1.5.5. Availability of suitable alternatives
A.2.01 Claiming uses in leather tanning and as cross-linking agent as intermediate
A.2.02 Questioning the volume score assigned	
				
4968
2022/05/02	COTANCE,
Industry or trade association,
France	The proposal by ECHA to include glutaral in the Authorization List (REACH) is the not the correct instrument to achieve any positive health or environmental effects, as such a move would not lead to positive effects on the health for consumers/workers and/or lead to environmental benefits.
The main potential risk with glutaral in connection with leather tanning is as skin sensitizers in leather. There is currently a restriction proposal made by Sweden and France (“restriction proposal on the placing on the market of textile, leather, hide and fur articles containing skin sensitizing substances”). It would cover all leather articles on the market in the EU including imported leather products. Therefore, the inclusion of glutaral in Annex XIV (Authorisation List) would not have any effect in relation to the protection of consumers since this already is covered by other legislation.
Glutaral is also characterized as a respiratory Sensitiser cat.1. This could potentially be a health problem for workers provided the actual use of glutaral in tanneries would not be safe. However, the use of glutaral in tanneries in the EU is safe. All tanneries in the EU are using a chemically modified form of glutaraldehyde which releases the chemical gradually during the tanning process. As a result of this, the concentration of glutaraldehyde in the process water will be kept low reducing the risk that glutaraldehyde will be emitted to the atmosphere in concentrations that could possess a health risk for the workers in the tannery.
We therefore do not believe that the proposal could be justified by any potential health risks for workers in the EU.
The third potential risk is the potential risk to the environment.  However, the EU BREF Document for the Tanning of Hides and Skins states the following “Glutaraldehyde is generally fully exhausted in the tanning process. Any residual glutaraldehyde that may reach the waste water treatment plant will react quickly with the proteins from other effluent streams and generally does not pose a problem in effluent treatment”.
Therefore, our opinion is that the proposal to include glutaraldehyde on the Authorisation List cannot be justified by environmental reasons.
We believe that a substantial part of the chromium-free production of leather in the EU will be moved outside the EU to countries with less stringent chemical control. It is very common that parts of the leather processes are done in other tanneries in multiple countries so logistically it will be no problem. If our concerns will come true, the actual result of the proposed legislation would be that this part of the production will take place outside the EU in countries with less strict chemical legislation.
	C.1.1. General principles for exemptions under Art. 58(2)
C.1.3. Aspects not justifying an exemption from authorisation

Please see also response to comment #
4794	

II - Transitional arrangements. Comments on the proposed dates
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3687
2022/04/22	Individual,
France	Diagnostica Stago wishes to comment on public consultation related to Glutaral - see confidential document attached (page 7).	Please see references to responses in section I	
		Confidential attachment removed
		
4137
2022/04/29	BASF SE,
Company,
Germany	Please see the attached document for BASF SE's comments.	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4137_111-30-8 GA Comments of the Lead registrant BASF SE to annex XIV prioritisation 20220429f.pdf		
4186
2022/04/29	Follmann-Chemie Gmbh & Co.KG,
Company,
Germany			
		Confidential attachment removed
		
4236
2022/04/29	German Association of the Automotive Industry (VDA),
Industry or trade association,
Germany			
		Confidential attachment removed
		
4265
2022/04/29	TFL Ledertechnik GmbH,
Company,
Germany			
		See the corresponding embedded attachment in Section I: 
4265_Glut Auth Comments SUBMISSION.pdf		
4279
2022/04/29	MedTech Europe,
Industry or trade association,
Belgium	Please refer to the attached submission.	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4279_MedTech Europe submission glutaral REACH Annex XIV.pdf		
4674
2022/05/01	Microbial Control (Netherlands) B.V.,
Company,
Netherlands		Please see references to responses in section I	
		See the corresponding embedded attachments in Section I: 
4674_GA as intermediate Leather_MC-NL.pdf

Confidential attachment removed		
4794
2022/05/02	Nordic Leather Research Council,
Industry or trade association,
Sweden	The Nordic Leather Research Council is aware that the LAD dates and sunset dates mainly are taking into consideration the time the concerned enterprises need to make an application for authorization and receive authorisation.
The leather industry mainly consists of small and medium-sized companies with very limited resources to apply for an authorization. We are aware that ECHA before have responded to similar comments that SMEs previously have applied for authorization either as single companies or as clusters. However, we do not believe this is realistic for tanneries since most companies in the sector in the EU are small companies with limited resources to elaborate an application for authorisation,
This aspect has also been discussed by the European leather industry and no enterprise has so far expressed any interest to apply for authorization taking the high fee and large amount of work into consideration (giving rise to high costs for consultants). In this connection, it should also be noted that it is very easy to move this part of the production to tanneries outside the EU (no investments necessary and technology already available for tanneries outside the EU).
If the proposal from ECHA regarding glutaral will be implemented, we believe that the sunset date should in this specific case be taking the development of alternatives into consideration and therefore be higher that 18 months which is mentioned in the proposal from ECHA.
	B.1.1.2. ECHA's proposal for sunset dates	
				
4968
2022/05/02	COTANCE,
Industry or trade association,
France	LAD dates and sunset dates mainly are taking into consideration the time the concerned enterprises need to make an application for authorization and receive authorisation.
The leather industry mainly consists of small and medium-sized companies with very limited resources to apply for an authorization.
This aspect has been discussed by the European leather industry and no enterprise has so far expressed any intention to apply for authorization taking into consideration the high fee and large amount of work (giving rise to high costs for consultants). In this connection, it should also be noted that it is more cost-effective to move this part of the production to tanneries outside the EU (no investments necessary and technology already available for tanneries outside the EU).
If the proposal from ECHA regarding glutaral will be implemented, we believe that the sunset date should in this specific case be taking the development of alternatives into consideration and therefore be higher that 18 months which is mentioned in the proposal from ECHA.
	B.1.1.2. ECHA's proposal for sunset dates	

III - Comments on uses that should be exempted from authorisation, including reasons for that
Number / Date	Submitted by (name, submitter type, country)	Comment	Reference to responses	
3670
2022/04/21	Deutsche Gesellschaft für Elektronenmikroskopie e.V. (German Society for Electron Microscopy),
Other contributor,
Germany	Glutaral is commonly used in scientific laboratories and in clinics applying electron microscopy for the purpose of research, diagnostics and in pathology. The chemical is indispensable in routine applications for the fixation of biological specimen during sample preparation for electron microscopy. These routine applications are performed under conditions in full compliance with work safety and health protection and thereby excluding any environmental or health risks. In clinical applications highest safety standards are mandatory for prevention of health risks imposed by potentially infectious human samples. Glutaral is used as important agent to inactivate infectious pathogens thereby ensuring save handling as well as tissue preservation. Glutaral has proven to be the best chemical for this application for decades. Important standard methods are based on it and switching to an alternative is impossible. An electron microscopy laboratory requires typically an average amount of 3-5 l of 25% aqueous Glutaral solution per year.	C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01 Exemption for research and development, medical sector, medical devices	
				
3687
2022/04/22	Individual,
France	Diagnostica Stago wishes to comment on public consultation related to Glutaral - see confidential document attached (page 1).	Please see references to responses in section I	
		Confidential attachment removed
		
3854
2022/04/27	Science Services GmbH,
Company,
Germany	Proposal of the exemption for the use in and the supply to industrial and scientific research laboratories and diagnostics.

Glutaral(dehyde) is commonly used as fixative for biological samples for electron microscopy in scientific and industrial laboratories. It is further used as fixative in clinical, histological and pathological diagnostics where electron microscopic resolution is required. The mentioned routine applications are performed in compliance with work safety, health protection and disposal is made to official regulations. Any environmental or health risks are therefore minimized.

Electron microscopy laboratories require typically an average amount of a few hundert milliliters to few litres of 25% aqueous Glutaral solution in very high purity (EM grade) per year.

As specialized distributor for electron microscopy laboratories we import an amount of 20-50 litres per year currently.
	C.1.1. General principles for exemptions under Art. 58(2)
C.1.2. Generic exemptions
C.1.3. Aspects not justifying an exemption from authorisation
C.2.01 Exemption for research and development, medical sector, medical devices	
				
4137
2022/04/29	BASF SE,
Company,
Germany	Please see the attached document for BASF SE's comments.	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4137_111-30-8 GA Comments of the Lead registrant BASF SE to annex XIV prioritisation 20220429f.pdf		
4186
2022/04/29	Follmann-Chemie Gmbh & Co.KG,
Company,
Germany			
		Confidential attachment removed
		
4236
2022/04/29	German Association of the Automotive Industry (VDA),
Industry or trade association,
Germany			
		Confidential attachment removed
		
4265
2022/04/29	TFL Ledertechnik GmbH,
Company,
Germany	Please refer to details given in the attachment	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4265_Glut Auth Comments SUBMISSION.pdf		
4279
2022/04/29	MedTech Europe,
Industry or trade association,
Belgium	Please refer to the attached submission.	Please see references to responses in section I	
		See the corresponding embedded attachment in Section I: 
4279_MedTech Europe submission glutaral REACH Annex XIV.pdf		
4674
2022/05/01	Microbial Control (Netherlands) B.V.,
Company,
Netherlands	Please, refer to the document attached in Section IV regarding use of glutaral in leather tanning.	Please see references to responses in section I	
		See the corresponding embedded attachments in Section I: 
4674_GA as intermediate Leather_MC-NL.pdf

Confidential attachment removed		
4794
2022/05/02	Nordic Leather Research Council,
Industry or trade association,
Sweden	The Nordic Leather Research Council proposes to exempt the use of glutaral in the tanning process from the authorization requirement. The justification for this request is given in other parts of this document.

The main comments from the Nordic Research Council can be summarized below:
• The use of glutaraldehyde in tanneries in the EU is safe without posing any risks to workers.
• The main risk with the use of glutaral in the tanning industry is already covered by upcoming future regulation (the restriction proposal on skin sensitizing substance).
• The consequence of the proposal would be that production most likely will be moved out from the EU. Jobs will disappear within the EU without giving any positive health or environmental effects in the EU
In summary, the Nordic Leather Research Council strongly advises ECHA not to propose to include the use of glutaral in tanning in the Authorisation List.
	C.2.02 Request for exemption for tanning	
				
4968
2022/05/02	COTANCE,
Industry or trade association,
France	COTANCE calls on ECHA to exempt the use of glutaral in the tanning process from the authorization requirement. The justification for this request is given in other parts of this document.
Main comments
• The use of glutaraldehyde in tanneries in the EU is safe without posing any risks to workers.
• The main risk with the use of glutaral in the tanning industry is already covered by upcoming future regulation (the restriction proposal on skin sensitizing substance).
• The consequence of the proposal would be that production most likely will be moved out from the EU. Jobs will disappear within the EU without giving any positive health or environmental effects in the EU
	C.2.02 Request for exemption for tanning

Please see also response to comment #
4794	
				
5053
2022/05/03	Verband TEGEWA e.V.,
Industry or trade association,
Germany	Verband TEGEWA e.V. proposes not to include glutaral in REACH Annex XIV with respect to the use as leather tanning agent. Based on chemical reaction of glutaraldehyde with skin (two bonds per molecule) and the stable bonds under consumer use conditions of leather articles an exposure of glutaraldehyde, especially exposure via inhalation, is very unlikely, too.
As exposure from leather articles is very unlikely, the main exposure, which has to be considered is the to workers via the use of glutaral as tanning agent in leather production, i.e. the focus to safely use glutaral is occupational health and safety. So, from the leather treatment perspective, occupational health and safety should be the appropriate measure to regulate glutaral in future.	C.2.02 Request for exemption for tanning