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

Substance name:	Phenolphthalein	
CAS number:	77-09-8	
EC number:	201-004-7	

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

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	
16	2011/10/13	National Authority
RIVM
Netherlands	Given the profile of the substance, it is suggested to first gather further information on the uses (other than laboratory use) with little or not information on use and related exposure and on the possible presence of the substance in articles before deciding on the appropriate risk management option to apply for this substance. 
However, NL supports the proposal to include Phenolphthalein in the candidate list of substances of very high concern. 
	Thank you for your comment and support. 

14	2011/10/12	Member State
Belgium	Belgium supports the identification of Phenolphthalein as SVHC according to article 57 (a)	Thank you for your support. 
	
13	2011/10/12	International NGO
Health and Environment Alliance
Belgium	HEAL supports the nomination of Phenolphthalein to the candidate list, based on the information in the Annex XV dossier.	Thank you for your support. 
	
12
11
(submit-ted twice)	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	We support Phenolphtalein entering the authorisation process.
Uses of phenolphthalein in working places had to be substituted due to the directive 2004/37/EC (on the protection of workers from the risks related to exposure to carcinogens or mutagens at work) already because there are less concerning alternatives. Perhaps the candidate list might help fulfilling this 7 year old requirement.
	Thank you for your support. 
	
10	2011/10/12	Company
Germany	Phenolphthalein is used as excipient and for analytical purposes. The following laboratory uses should be exempted from the authorisation because they are within the scope of scientific R&D. The exposure to consumers and the environment is very low. 	Thank you for your comment.

Scientific research and development (SRD) is exempted from the authorisation requirement, according to Art. 56(3) REACH. If the conditions of SRD are fulfilled would need to be checked at a later stage of the risk management process in case further regulatory measures are taken. 
	
8	2011/10/10	Trade union
European Trade Union Confederation
Belgium	ETUC supports the identification of phenolphthalein as SVHC.	Thank you for your support. 
	
7	2011/10/07	International NGO
ChemSec
Sweden	We fully support the inclusion of this substance into the candidate list.	Thank you for your support. 
	
5	2011/10/06	International NGO
WWF European Policy Office
Belgium	WWF supports the inclusion of this substance in the candidate list owing to its classification as carcinogen category 1B.	Thank you for your support. 
	
4	2011/10/06	Member State
Norway	The Norwegian CA supports that phenolphthalein should be identified as a substance of very high concern and should be included in the Candidate List.	Thank you for your support. 
	
3	2011/10/06	Company
Hach Lange GmbH
Germany	Phenolphthalein is used as an indicator in the chemical analysis in a concentration range of 0.5%. 	Thank you for that information.	
1	2011/09/23	Individual
Germany	I cannot find scientifically sound links between Hazards and the exposure assessment.
Moreover according to the dossier all potential risks associated with the only relevant laboratory uses of Phenolphthalein seem to be perfectly under control due to the risk management measures normally applied.
Note that medical products and workplace safety prescriptions are usually regulated under other pieces of legislation.
The chemicals legislation is therefore not an appropriate vehicle to introduce further risk management measures into these fields.
There is no evidence for other significant uses of Phenolphthalein (i.e. no risks are identified) in the public part of the dossier, because the Phenolphthalein on the market seems to be almost quantitatively used for laboratory purposes.
I therefore recommend to withdraw the proposal to classify Phenolphthalein as a candidate substance.
	Thank you for your comment. 

Please note that the Annex XV report does not aim for assessing the risks arising from the use of phenolphthalein but rather to justify that the substance meets one or more criteria of Art. 57 (Part I) and to report information which could be useful in the further authorisation process, in particular for prioritisation, e.g. tonnages, wide-dispersiveness of uses (Part II), in case further regulatory measures are taken.

			See also:
Comment 1 attachment (Phenolphthalein literature search results.zip).zip		

Specific comments on the justification
Number	Date	Submitted by (name, Organisation/MSCA)	Comment	Response	
17	2011/10/13	Member State
Ireland	Phenolphthalein is classified as Carc. 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 (a) of REACH. 

We note that a specific concentration limit (Carc. 1A H350: C ≥ 1 %, which is to be corrected to Carc.1B in a correcting ATP to CLP) applies for phenolphthalein and the corrected specific concentration limit should be carried forward to the candidate list entry for this substance.	Thank you for your support. 

The Annex XV report addresses the pure substance. Therefore, it is of no relevance for the identification of phenolphthalein as SVHC if there is a specific concentration limit given in the CLP. Such specific concentration limits are needed to classify dangerous mixtures containing the substance.
	
15	2011/10/13	Member State
Sweden	The Swedish CA agrees that phenolphthalein, being classified as Carc. 1B, meets the criteria according to Article 57(a) in REACH and is thus eligible for identification as a substance of very high concern.
	Thank you for your support. 
	
1	2011/09/23	Individual
Germany	Page 0
I found no scientifically sound reason in the dossier, why Phenolphthalein should become a “candidate” substance.
The dossier itself states that there is no relevant hazard for humans (page 4) and none for the environment (page 5).
Page 0 states that Phenolphthalein is proposed as a “candidate” substance because of the classifications as “carcinogenic” category 1B1
which corresponds to classification as carcinogen category 2.
Note that these classifications apply only in concentrations >= 1 %.
The dossier does not report the route of administration on which these classifications are based.
In my literature search (see below) I only found results for oral tests with mammals (mice and rats).
The TD50 are in the range of 1000 mg/kg/day.
For humans (75 kg) this corresponds to 75 g/day over several weeks!
I found no evidence in the dossier that oral application is a relevant route of administration of Phenolphthalein for humans (or mammals).
The dossier only evaluates skin contact for which I found no test results indicating any carcinogenic effect on mammals.	Please note that Sections 3, 4 and 5 of Part I of the Annex XV report (p. 5-7) don’t need to be filled in if - as is the case for phenolphthalein – a classified CMR substance is proposed to be identified as SVHC in accordance with Art. 57a, b or c.   

Phenolphthalein has a harmonised classification as Carc. 1B and is included in Annex VI of Regulation 1272/2008. That classification is the basis for proposing the substance for identification as SVHC. 

Please note further that the Annex XV report addresses the pure substance. Therefore, it is of no relevance for the identification of phenolphthalein as SVHC if there is a specific concentration limit indicated in the CLP. 
  	
			See also:
Comment 1 attachment (Phenolphthalein literature search results.zip).zip		

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	
12
11
(submit-ted twice)	2011/10/12	National Authority
Allgemeine Unfallversicherungsanstalt
Austria	P19
Definitely there are many alternatives (different acid-base indicators and glass electrodes) of phenolphthalein in pH-measurement and for the use as a laxative as well. 
	Thank you for that information.	
10	2011/10/12	Company
Germany	The substance is used as such, in a preparation or solution as an indicator by industrial and professional users.
These applications are routine analytical uses in a laboratory within the scope of scientific R&D. The risk for the environment and consumers is very low. Usually the volumes and the concentration of the substance are low. The disposal of the substance is also controlled.

Additionally, the substance is described in Ph. Eur as excipient. The use as excipient is exempted from authorisation and the filling/packaging for scientific R&D purposes and for use as excipient should also be exempted.
	Thank you for your comment.

Information on use and exposure could be of relevance at later stages of the risk management process. 
	
9	2011/10/11	Member State
Germany	Information on uses

p.11: There is no such thing as „the“ tumour suppressor gene, many tumour suppressor genes have been identified so far – therefore the statement is ambiguous.

p. 13 Use #3: Use in other specialist applications
Phenolphthalein is a suspected ingredient in wall paints which change their colour when drying. (ÖkoTest 2006)
Phenolphthalein is used as a special indicator to determine the depth of carbonation of concrete. (BS EN 14630)

p.14: Use #4: Formulation of pharmaceutical preparations:
Phenolphthalein has been detected by Swissmedic, the Swiss Agency for Therapeutic Products as an undeclared ingredient in slimming products declared as herbal. According to Swissmedic, there is a rising number of reports of falsified slimming products containing non-declared Sibutramin, Phenolphthalein, Rimonabant or Phenytoin from foreign other regulatory authorities (USA, Canada, Singapore, France, Austria and Bulgaria) since the beginning of 2008. (Swissmedic 2009)

References:

BS EN 14: Products and systems for the protection and repair of concrete structures. Test methods. Determination of carbonation depth in hardened concrete by the phenolphthalein method. 

Öko-Test (2006): ÖKO-TEST Jahrbuch Bauen, Wohnen, Renovieren für 2006, http://77.90.130.41/cgi/index.cgi?artnr=38400;bernr=01;co, retrieved on 20 September 2011

Swissmedic (2009): Swissmedic identifies dangerous substances in slimming products claimed to be herbal.  http://www.swissmedic.ch/aktuell/00003/00940/index.html?lang=en, retrieved on 20 September 2011

Information on alternative substances and techniques

p.19: We don’t think that a simple general list of pH-indicators can be counted as a list of alternatives. The use characteristics of pH indicators are generally characterized by their pH transition range. Tropeolin OO has a pH-range of 3 to 3.2, bromcresol green of 4 to 5.6 and bromphenol blue of 3 to 4.6. Phenolphthalein on the contrary covers pH-range from 8.2 to 10. Therefore we conclude that none of the aforementioned indicators can replace phenolphthalein. Identification of potential alternatives deserves more effort.	Thank you for your comment and the information provided.

Regarding the alternatives, we agree that the listed acid-base indicators cover a wide pH range also outside the range of phenolphthalein. However, it is also explicitly stated in the Annex XV report that the given acid-base-indicators are just examples, and that they may not be direct replacements for phenolphthalein. 	
6	2011/10/06	Company
United States	The applications of phenolphthalein listed in the dossier (> pg. 10) do not include its use as a humidity indicator for use with desiccants (such as silica gel). This is a relatively new application for the substance, driven primarily as a result of the current widely used indicator, CoCl2, being added to the SVHC Candidate List in 2009. The desiccant industry reacted to the inclusion of CoCl2 by identifying phenolphthalein as the most reliable alternative. Should phenolphthalein also be restricted, indicating desiccants may become unavailable. They are used widely in many industries including the in vitro diagnostic industry. They are used to alert customers not to use a diagnostic kit which has been inadvertently exposed to high humidity. High humidity will render the device unfit for accurate use. While in vitro diagnostic and medical devices are exempt for authorization for use of SVHCs, supply may become a concern. Without the availability of an indicator (either CoCl2 or phenolphthalein) some in vitro diagnostic products may become unavailable. 	Thank you for the information on this use of phenolphthalein. 

Information on use, exposure and the availability of alternatives could be of relevance at later stages of the risk management process. 
	
3	2011/10/06	Company
Hach Lange GmbH
Germany	The specific concentration limit in Annex VI for H350 is >1%. So, there is no cancerogenic hazard for the user in the concentration range the substance is normally used in the reagents.  
	Please note that the Annex XV report addresses the pure substance. Therefore, it is of no relevance for the identification of phenolphthalein as SVHC if there is a specific concentration limit given in the CLP.
  	
2	2011/09/29	Company
Germany	Page 13, Chapter 2.2.2 "Use #2: Laboratory Use" describes the use of Phenpolphthalein (P) as pH indicator. The last paragraph concludes that the indicator use of P will likely be exempt because of Art. 56(3).
Please take into consideration that P is used as pH indicator in the industry in analytical labs for process monitoring as well. In these labs P is used under the same controlled conditions as in scientific R&D labs, i.e. use of small amounts in solutions with concentrations of 1% and  without exposure to workers or the environment. In some processes (esp. semiconductor manufacture) there is no possibility of substitution of P. Therefore, the pH indicator use of P at industrial laboratories should be exempt as well as the R&D lab use.
	Thank you for your comment. 

Information on use, exposure and the availability of alternatives could be of relevance at later stages of the risk management process. 
	
1	2011/09/23	Individual
Germany	Use:
The solubility of Phenolphthalein in water is very low (approximately < 0,01 %).
Therefore Phenolphthalein is usually stored in approximately 0,1 % (weight/weight) ethanolic solution as a reagent in laboratories.
According to my experience as a chemist only a few drops of these storage solutions are used in e.g. 100 ml of water as a pH-reagent.
Exposure:
The resulting Phenolphthalein concentrations to which humans could be exposed by spillage may therefore be smaller compared to the estimations in the dossier.
Usually potential exposure will be further reduced, because people will normally wash spills away.
Risk:
I found no evidence in the dossier that humans or the environment are exposed to amounts of Phenolphthalein which might lead to adverse effects according to test results.
Therefore I cannot see any risk associated with Phenolphthalein (no relevant exposure = no risk).	Thank you for your comment. 

Information on use and exposure could be of relevance at later stages of the risk management process.

Please refer also to response given above. 	
			See also:
Comment 1 attachment (Phenolphthalein literature search results.zip).zip		

Attachments

Comment number	Public attachment	Confidential attachment	
1	
Comment 1 attachment (Phenolphthalein literature search results.zip).zip