COMMENTS ON AN ANNEX XV DOSSIER FOR IDENTIFCATION OF A SUBSTANCE AS SVHC AND RESPONSES TO THESE COMMENTS

Substance name:	Formamide	
CAS number:	75-12-7	
EC number:	200-842-0	

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: 

Disclaimer: comments provided during public consultation are made available in this document as submitted by the webform. It was in the “interested parties” own responsibility to ensure that no confidential information was included in the comments. In addition, ECHA is not responsible for the content of the responses prepared by Member States.

PART I: Comments and responses to comments on the SVHC proposal and its justification

General comments on the SVHC proposal
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
14	2012/04/13	Company
Germany	Basic Information:
Formamide has been registered mainly as Transported Isolated Intermediate (TII) (>1000 tonnes/year) according  to Article 18 REACH.
In addition the substance has been registered in the lowest tonnage band (1-10 tonnes/year) for specific enduses in industrial and professional environment  as solvent & reagent for laboratory and analytical applications. 
The substance has not been registered for any consumer use or for the production of articles in Europe.
We are aware of the appearance of formamide in puzzle mats for children and other foam mats imported from Asia into Europe. We are concerned about this and support any effort to control this risk of exposure to the general public by appropriate and efficient measures.
Nevertheless we believe that there are more efficient regulatory measures to reach this target and that listing formamide as SVHC substance and possible further authorisation is not the appropriate way according to the criteria laid down in Art. 58 REACH
	Thank you for the information on uses of formamide. 
Intermediate use is exempted from authorisation. Identification of formamide as SVHC indeed aims at the uses in consumer products. The requirements for inclusion in the Candidate list are met by hazard criteria. Information requirements apply for those articles containing more than 0.1 % (w/w) formamide.
Further criteria according to Art. 58 REACH will only play a role in the next step which has to be decided on after reception of the information sought.	
			See also:
Comment 14 attachment (Comment_Formamide_ROI_Consultation_2012.pdf).pdf		
13	2012/04/12	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as toxic to reproduction category 1 B. 	Thank you for your support.	
12	2012/04/12	Company
Finland	To whom it may concern,

We understand that the presence of formamide in children’s toys has drawn the attention and we support any appropriate action and effective measure to avoid any exposure to the general public, and in particular the most sensitive group namely children. 

However, we do not believe that consumer exposure of formamide can be effectively limited by nominating formamide as a SHVC substance within the REACH regulatory framework:

-	Professionals working in an industrial and laboratory environment in the EU, are operating under exposure controlled conditions and they are using appropriate protection equipment. 

-	Authorization of formamide under REACH will rather affect the professional and ‘low-risk’ uses in the EU. The financial burden and workload of an authorization by laboratories can be considered disproportionate to their small scale formamide use under exposure controlled conditions.  

-	The origin of the presence of formamide in children’s toys and consumer products is not clear. It is assumed that the formamide in foam-consumer products is a by-product from the article production chain. There are no known REACH registered uses of formamide in articles. Restriction of specific formamide uses will not result in the restriction of formamide  as a by-product in articles.     

-	Nearly all toys are coming from Asia. Production and uses in Asia are not in the scope of REACH. 

Last year, the French competent authorities were planning to draft an annex XV dossier for proposing formamide as a SVHC. This was after formamide was detected in imported children’s toys. Based on the arguments as provided here, they were convinced not to proceed with the process of having formamide identified as an SHCV substance.
	Thank you for your comment.
Identification of formamide as SVHC indeed aims at the uses in consumer products. 
The requirements for inclusion in the Candidate list are met by hazard criteria. Information requirements apply for those articles containing more than 0.1 % (w/w) formamide.
Further criteria according to Art. 58 REACH will only play a role in the next step which has to be decided on after reception of the information sought. 
The possible exposure of consumers through articles can be reduced e.g. by restricting the use in certain products including imported ones. This also includes the use of alternative blowing agents instead of the two identified formamide releasers.	
			See also:
Comment 12 attachment (Additional information Comments formamide.pdf).pdf		
11	2012/04/12	Company
Finland	To whom it may concern,

We understand that the presence of formamide in children’s toys has drawn the attention and we support any appropriate action and effective measure to avoid any exposure to the general public, and in particular the most sensitive group namely children. 

However, we do not believe that consumer exposure of formamide can be effectively limited by nominating formamide as a SHVC substance within the REACH regulatory framework:

-	Professionals working in an industrial and laboratory environment in the EU, are operating under exposure controlled conditions and they are using appropriate protection equipment. 

-	Authorization of formamide under REACH will rather affect the professional and ‘low-risk’ uses in the EU. The financial burden and workload of an authorization by laboratories can be considered disproportionate to their small scale formamide use under exposure controlled conditions.  

-	The origin of the presence of formamide in children’s toys and consumer products is not clear. It is assumed that the formamide in foam-consumer products is a by-product from the article production chain. There are no known REACH registered uses of formamide in articles. Restriction of specific formamide uses will not result in the restriction of formamide  as a by-product in articles.     

-	Nearly all toys are coming from Asia. Production and uses in Asia are not in the scope of REACH. 

Last year, the French competent authorities were planning to draft an annex XV dossier for proposing formamide as a SVHC. This was after formamide was detected in imported children’s toys. Based on the arguments as provided here, they were convinced not to proceed with the process of having formamide identified as an SHCV substance.
	See response to comment 12.	
			See also:
Comment 11 attachment (Additional information Comments formamide.doc).doc		
10	2012/04/12	Member State
Finland	The Finnish CA agrees that formamide meets the criteria as SVHC according to article 57(c). In order to assess whether inclusion in Annex XIV is also appropriate we agree that more information is needed on the uses and likelihood of the exposure. The coverage of the new Toys Safety Directive 2009/48 should be considered in the future when deciding on the inclusion of formamide in the Annex XIV.  	Thank you for your comment.
The Directive has been considered (Part II, Annex XV dossier) however not all articles with formamide will be covered by the Directive.	
8	2012/04/11	Company
United Kingdom	The purpose in submitting these comments is to ensure that ECHA is familiar with certain critical uses of Formamide. Our use of Formamide is in small volumes as a laboratory reagent for quality control purposes. This is a critical use for the release of our specialized DNA storage papers to our customers, especially in the area of forensics/human identification.
Inability to use Formamide as an analytical reagent for quality control purposes will directly impact production and quality of DNA storage and capture devices, which in turn will have a knock on effect on the following industries; pharmaceutical, research & development, medical and public sectors (such as the army, police, forensic) in DNA analysis.
Formamide is used in the characterization of our products and in:
1. Forensic laboratories – From forensic investigations to plant studies in remote locations,
the product range provides a simple and convenient way to collect DNA samples and safely store them at room temperature on a small card. The technology has potential
uses in many diverse areas where human identification is important, including crime
investigation, military casualties, immigration, and paternity investigations. Forensic
laboratories use kits routinely containing Formamide to perform their DNA sequencing
analyses. Therefore, the forensic laboratories are as well concerned by the possible
inclusion of Formamide on the Candidate list.
2. Hospitals – The product range is the international standard for body fluid sample
collection and analysis. The product range is used in most screening programmes for
new-born babies throughout the world to identify babies who may have rare but serious
conditions, enabling rapid diagnosis and treatment.
3. Pharmaceutical companies – The products can also be used by pharmaceutical
companies in their drug metabolism studies. A crucial part of the drug development
process involves studying how potential new drugs are metabolised in the body. The
products ensure that across products and batches, every tablet contains precisely the
correct amount of the drug.
4. Food and drinks manufacturers – Our products are used in a wide range of quality control
applications, including analysing caffeine, clarifying fruit juices and mineral water, and
monitoring for harmful bacteria. They are used in the manufacture of many everyday
products you see on supermarket shelves.
5. Research laboratories – The products are designed for use in laboratories working with
DNA and proteins. The products help researchers to prepare, purify, analyse, detect and
measure DNA and proteins. These activities are vital in many different types of biological
research, and our products are used in several types of laboratories, from universities to
pharmaceutical companies.
Formamide is not present in the final products that we place on the market and hence is no
potential exposure to Formamide to the end users.
Formamide is handled in our Quality Control laboratories under controlled conditions.
There are currently no other known substances that could replace the use of Formamide as an
analytical reagent for quality control.
Any future work on interchangeability or substitution of Formamide as an analytical reagent for
quality control may not necessarily provide a consistent quality control test method.
Our finished products are used in highly regulated industries and the inability to use Formamide as
an analytical quality control tool will be highly detrimental along the supply chain.
The described use may fall under the exemption of scientific research and development (SRD) in
accordance with Article 56(3) of the REACH Regulation. Article 3(23) defines SRD as “any
scientific experimentation, analysis or chemical research carried out under controlled conditions in
a volume less than 1 tonne per year”.
It is noted that SRD covers analysis for e.g. monitoring and quality control purposes, as long as
the chemical substances used for this analysis are used under controlled conditions and in a volume of less than one tonne per year.
We suggest and request confirmation that our use of Formamide be regarded as exempt in accordance with the definition set out in Article 3(23) for scientific research and development.	Thank you for the information on uses of formamide.
The requirements for identification of formamide as SVHC and inclusion in the Candidate list are met according to article 57(c). Afterwards information requirements apply for articles containing more than 0.1 % (w/w) formamide. Further criteria like amounts and uses according to Art. 58 REACH will only play a role in the prioritisation step for inclusion in Annex XIV. Intermediate use and use in scientific research and development are in general exempted from authorisation.	
7	2012/04/11	Member State
Sweden	The Swedish CA agrees that formamide, being classified as Repr. 1B, meets the criteria according to Article 57(c) in REACH and is thus eligible for identification as a substance of very high concern.	Thank you for your comment.	
6	2012/04/11	Member State
Norway	The Norwegian CA supports that formamide should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support.	
5	2012/04/11	Individual
United Kingdom	Formamide is used routinely in small volumes for DNA profiling for use in forensics and paternity testing.  The current methods using formamide have all had to go through extensive optimisation and validation work.  If the use of formamide were to be banned then this would have a negative effect on these processes.  It would involve a lot of research and develoment work to try and find a suitable alternative which may not be able to produce as good results and would require potential changes to expensive equipment and methods to be optimised and validated.  This could cause a big backlog in sample processing and lead to a delay in the criminal justice system, there would also be an associated cost with making such changes.	Thank you for the information on uses of formamide.
The requirements for identification of formamide as SVHC and inclusion in the Candidate list are met according to article 57(c). Afterwards information requirements apply for articles containing more than 0.1 % (w/w) formamide.	
4	2012/04/10	Company
BASF SE
Germany	Please find our comments attached.	Thank you for your comment.
Identification of formamide as SVHC indeed aims at the uses in consumer products. 
The requirements for identification of formamide as SVHC and inclusion in the Candidate list are met by the hazard criteria according to article 57(c). 
Further criteria according to Art. 58 REACH will only play a role in the next step which has to be decided on after reception of the information sought. We agree that the amounts for other than intermediate uses are low. The possible exposure of consumers through articles can be reduced e.g. by restricting the use in certain products including imported ones. This also includes the use of alternative blowing agents instead of the two identified formamide releasers but not formamide itself.	
			See also:
Comment 4 attachment (comments to Formamide SVHC finaldoc_CAS71-12-7.pdf).pdf		
3	2012/04/06	Member State
Belgium	Belgium supports the identification of Formamide as SVHC according to article 57 (c)	Thank you for your support.	
1	2012/03/30	Member State
United Kingdom	The fact that no exposure assessment or risk characterisation was provided on registration implies that less than 10 tonnes/year are supplied for non intermediate uses. The risks from these uses is not clear.

We do not think that this substance would be a high priority for inclusion in Annex XIV.
	Thank you for your comment. We agree on the points made. No Chemical Safety Report has been provided for formamide because it is not required for the registration. Taking into account the strictly controlled conditions for intermediate use and the presumably limited exposure for laboratory chemicals the risks for workers in industrial settings and professional users are considered to be controlled. However, it should not be forgotten that also workers and professionals do use articles. As formamide was measured in consumer products and probable exposure is indicated consumers might be at risk.	

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
9	2012/04/11	Member State
Ireland	Formamide is classified as Repr. 1B according to Regulation EC No. 1272/2008, and therefore the Irish CA agrees that the substance meets the criteria for identification as an SVHC in accordance with Article 57 (c) of REACH.	Thank you for your comment.	
8	2012/04/11	Company
United Kingdom	There are currently no other known substances that could replace the use of Formamide as an analytical reagent for quality control to obtain the same results.
Any future work on interchangeability or substitution of Formamide as an analytical reagent for quality control may not necessarily provide a consistent quality control test method.
The use of water has been tested as a possible substitute for Formamide in the quality control and DNA test. Results showed:
1. Formamide and water are good denaturing solvents; however, water will decompose DNA, thus impacting on the DNA sequencing result.
2. Formamide is more effective (in what aspect) when working with larger DNA fragments and higher concentrations of DNA.
3. Formamide, an oily liquid with low volatility, is less likely to evaporate than water.  Therefore, it is more adapted for experiences taking long time and fully ensuring
denaturation of DNA.
4. Formamide, unlike water, maintains the DNA in a denatured state, even under these circumstances:
a. In the presence of the alkaline stabilizer EDTA
b. When the sample remains at room temperature for extended time periods on the instrument 	Thank you for your information on alternatives for formamide.	
1	2012/03/30	Member State
United Kingdom	We agree that formamide meets the hazard criteria for inclusion on to the Candidate List.	Thank you for your comment.	

PART II: Comments and responses to comments on uses, exposures, alternatives and risks

Specific comments on use, exposure, alternatives and risks
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
14	2012/04/13	Company
Germany	Part II  1.1
General solvent use for production of leather and inks has currently not been registered for higher tonnage band in Europe. Only use for special analytical application has been registered in the lowest tonnage band (1-10to/y). 

Part II  1.2
It can be confirmed that the use of formamide in laboratory reagent and analytical applications in an  industrial or professional environment gives only limited or no chance for exposure and under the appropriate risk management measurements according to the SDS.
We fully agree that "There is currently no evidence that would suggest that worker exposure levels to formamide present an unacceptable risk."

Part II  1.3
All information provided in this paragraph and by the ANSES dossier strongly suggest that formamide occurrence in children puzzle mats and other foam mats results from the foaming agent which releases formamide during its mode of action. There is no hint that formamide itself is used in the production of the foam mats. All mats are import products from Asia and not produced in Europe (see information about use & REACH registration dossier: no uses of formamide for production of articles have been registered!) Only a small number of examined foam mats and toys (only 5 of 40) contained more than 0,1% formamide which is the regulatory level that stipulates reporting duties.
All these facts together show that listing of formamide on the candidate list and possible further authorisation will not be an efficient and fast way to control and reduce the risk of the presence of formamide in children toys and other consumer products. Other regulatory measures will be more effective to achieve the desired protection against formamide in consumer products.
	Thank you for the information on uses of formamide.
Identification of formamide as SVHC indeed aims at the uses in consumer products. 
The requirements for identification of formamide as SVHC and inclusion in the Candidate list are met by the hazard criteria according to article 57(c). Afterwards information requirements apply for articles containing more than 0.1 % (w/w) formamide. 
Further criteria according to Art. 58 REACH will only play a role in the next step which has to be decided on after reception of the information sought. We agree that the amounts for other than intermediate uses are low.
If sufficient information will be available, the possible exposure of consumers through articles can be reduced e.g. by restricting the use in certain products including imported ones. This also includes the use of alternative blowing agents instead of the two identified formamide releasers.	
			See also:
Comment 14 attachment (Comment_Formamide_ROI_Consultation_2012.pdf).pdf		
8	2012/04/11	Company
United Kingdom	Under foreseeable conditions of use there is no worker exposure to our use of this substance.
The substance is handled under good laboratory practice. Personnel protective equipment, such as protective glasses, lab coat and gloves are worn by the operator when handling Formamide. All operations are performed under fume hoods under controlled conditions.
The volumes handled at any one time do not exceed 15ml and the solution is never removed from the container.
Thus, there is no inhalation or dermal exposure in the use of the Formamide as a reagent in Quality Control of product for DNA storage and control devices.	Thank you for the information on worker exposure. We agree that there is currently no evidence that would suggest that worker exposure levels to formamide present an unacceptable risk	
2	2012/04/05	Company
Germany	Formamide is used in scientific research and development. Additionally, the substance is described in standard references like e.g. Reag. Ph. Eur and ACS.	Thank you for your comment. 
Use in scientific research and development are in general exempted from authorisation.	
1	2012/03/30	Member State
United Kingdom	Section 1.1 - No information is given as to the tonnage of formamide that would come within scope of any authorisation. It would be helpful to have an idea of the
volumes in the different uses to have a better idea of the wide –dispersiveness.

Section 1.2 – the document states ‘there is currently no evidence that would suggest that worker exposure levels to formamide present an unacceptable risk’. However little evidence is presented to back up this statement.

Section 1.3 – Although some information is given in this section on where formamide has been found in consumer products there is little indication of the actual risks that might result from use of these.

Section 2 – Little information is provided on alternatives, their applicability and the risks.

Section 3 – Very little information is provided.

The proportionality of the measure proposed needs to be discussed as addition to the Candidate List creates a regulatory duty for every article producer or importer in the EU and may not produce the information sought. This option could impose a major regulatory burden on many thousands of potential duty holders to obtain information from relatively few actual duty holders. 
	From the tonnages in the full registrations it is expected that 10-100 t might fall in the scope of authorisation.

The statement “there is currently no evidence that would suggest that worker exposure levels to formamide present an unacceptable risk” reflects the current status of knowledge. There is no further evidence available at the German CA that might help to back up this statement. 

The requirements for inclusion in the Candidate list are met by hazard criteria.

No current information was readily available. 

No CSR has been provided.

Information requirements are only applicable for those producing articles containing more than 0.1 % (w/w) formamide. For these articles information is sought.	

Attachments

Comment number	Public attachment	
4	
Comment 4 attachment (comments to Formamide SVHC finaldoc_CAS71-12-7.pdf).pdf	
11	
Comment 11 attachment (Additional information Comments formamide.doc).doc	
12	
Comment 12 attachment (Additional information Comments formamide.pdf).pdf	
14	
Comment 14 attachment (Comment_Formamide_ROI_Consultation_2012.pdf).pdf