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

Substance name: Benzo[def]chrysene (Benzo[a]pyrene)
CAS number: 50-32-8
EC number: 200-028-5

The substance is proposed to be identified as meeting the following SVHC criteria set out in Article 57 of the REACH Regulation: Carcinogenic (Article 57 a); Mutagenic (Article 57 b); Toxic for reproduction (Article 57 c); PBT (Article 57 d); vPvB (Article 57 e)

Disclaimer: Comments provided during public consultation are made available as submitted by the commenting parties. It was in the commenting parties own responsibility to ensure that their comments do not contain confidential information. The Response to Comments table has been prepared by the competent authority of the Member State preparing the proposal for identification of a Substance of Very High Concern. RCOM has not been agreed by the Member State Committee nor has the document been modified as result of the MSC discussions.  

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, submitter type, country)	Comment	Responses	
4595
2016/04/14	Concawe,
Industry or trade association,
Belgium	Concawe has several reservation on the proposal to the SVHC procedure for Benzo(a)pyrene (B(a)P), as this substance is not registered and, therefore, will not lead to follow-up activities indicated in the REACH Regulation.
Given, that B(a)P is not registered there is registration dossier or Lead-registrant responsible for the adequate, comprehensive and complete data collection of all properties relevant for the SVHC assessment. This means that either the Rapporteur or ECHA will have to perform this role in an objective and impartial assessor.  Hence, a full data search in the open and grey literature, accompanied by verifiable rationales for the choices made, as also is expected from any lead registrant defending their substances, should be presented. As this is not present in this report for any research published after 2004, the report is incomplete and should never have been accepted for a public consultation.
Finally, the name give to the substance by the Rapporteur is experienced by most of our specialists as misleading and inquiring in Industry, this week, it has surfaced that several interested stakeholders have overlooked the consultation and, therefore, probably have supposed the opportunity to provide new and relevant information in this process.	Thank you for your comments. 

As a registration is not mandatory for the SVHC identification of a certain substance and the information in this particular proposal was mainly derived from previous assessments that have already been agreed on by the Member State Committee, we do not see how the lack of a lead registrant should cause a disadvantage in this case.

Although we agree that the substance name used in this SVHC proposal is less common, we like to point out that Benzo[def]chrysene is the EINECS and an IUPAC name of the substance. Therefore it is no unknown name as it is used for the EINECS entry. Additionally, the rather more commonly known name Benzo[a]pyrene was stated in brackets and further identifiers such as the CAS and EC numbers were given in the SVHC dossier as well. Therefore, the substance name will not be amended throughout the SVHC dossier.

In the following, we would like to respond to various points raised by CONCAWE in the attached document “4595_B(a)P SVHC proposal dossier”: 

CONCAWE remarks critically that only comparably old references have been used in the SVHC proposal. This is due to the fact that mainly information provided in the RAR for CTPHT has been used for the dossier. Based on this older but still valid information also provided in the SVHC dossier for CTPHT, the Member State Committee has already concluded on the PBT and vPvB properties of B[a]P. 

Overall we come to the conclusion that no relevant new information was provided by CONCAWE that is able to refute the identification of B[a]P as being a PBT and a vPvB substance. Detailed responses are given in the following.

Persistence

CONCAWE considers photo-degradation as the most relevant degradation mechanism for B[a]P in the environment and is of the opinion that this degradation pathway is the underlying reason for the discrepancy between measured concentrations of B[a]P in the environment and known emission volumes for the substance. Moreover, CONCAWE does not support the conclusion that B[a]P fulfils the vP criterion.

It is clearly stated in the SVHC dossier that photo-degradation indeed occurs in the environment. In air, however, B[a]P binds rapidly to fine particles and particle-bound B[a]P degrades very slowly. In water, photo-degradation occurs only in the upper few centimetres of the water column. Therefore, it is concluded that photo-degradation is not considered as a relevant degradation process in water and terrestrial environments. In line with this, Haritash & Kaushik (2009) state in their review with the title “Biodegradation aspects of PAHs” which was cited in CONCAWE’s comment that PAHs do not degrade easily under natural conditions. It is rather described that PAHs are the main pollutants in air while soil acts as the ultimate depository of these chemicals.

We agree that bioremediation is an effective measure to remove PAHs from soil. However, microorganisms extracted and cultured in the laboratory are usually added to the contaminated soil after they have adapted to the new energy source. Moreover, supplements (e.g. glucose) are added as well for optimizing growth. Haritash & Kaushik (2009) state: “Studies have shown that bacteria can degrade BaP when grown on an alternative carbon source in liquid culture experiments. Ye et al. observed a 5% decrease in BaP concentration after 168h during incubation with Shingomonas paucimobilis strain EPA 505 grown on nutrient agar supplemented with glucose…” Thus, in our opinion those remediation techniques do not show a degradation in the natural environment and are therefore not relevant for the identification of B[a]P as a SVHC. 

Additionally, CONCAWE argues that the process of “aging” reduces the exposure and therefore the associated risks. But since the “aging” phenomenon was elaborated in the laboratory, there are no information available whether PAHs that are strongly sorbed to soil particles may be released when environmental conditions change (such as changes in pH, temperature, moisture,…). Thus, soil may only be a temporary sink for PAHs. Moreover, from our point of view, the phenomenon of aging might rather be the underlying reason for the discrepancy between the amounts of B[a]P found in the environment and the amounts emitted. We do not share CONCAWE’s view that this is due to massive degradation via photolysis.

The fact that biodegradation occurs in the environment has been included in the SVHC proposal. But even considering that some microorganisms may be able to degrade B[a]P under very specific conditions does not disqualify the assessment that the substance still fulfils the P and vP criteria.

Concerning the comment regarding co-metabolism, we agree that for some PAHs degradation is possible when other chemicals are present. However, high concentrations of other substances –e.g. naphthalene – may as well inhibit degradation due to their toxicity. Since this additional information is superfluous for decision-making on the persistency of B[a]P, we do not include the information into the SVHC dossier. 

In conclusion, CONCAWE did not provide relevant information to refute the persistency of B[a]P under environmental conditions.

Bioaccumulation

CONCAWE argues that data derived by BMF, BSAF, and TMF should be included and considered for the B assessment. Additionally, CONCAWE does not support the conclusion that B[a]P fulfils the B and vB criteria. 

However, the most sensitive organisms towards PAHs are those lacking a cytochrome P450 enzyme system. It has been shown without a doubt that bioaccumulation occurs in those organisms because they cannot degrade PAHs. This has been clearly assessed in the SVHC proposal. There is no reason to include further data - even if it is newer - on organisms which are able to degrade PAHs as the existence of such organisms with no detectable bioaccumulation of B[a]P is not the question to be assessed. Thus, we decide against including the data provided by CONCAWE into the SVHC report because it does not affect the conclusion that B[a]P fulfils the B and the vB criteria.

Toxicity

CONCAWE argues that while in the persistence section of the SVHC proposal, photo-degradation is seen as no relevant degradation pathway of B[a]P in the environment, photo-enhanced toxicity is considered plausible in the aquatic environment on the other hand. From our point of view, this is no contradicting information. In the upper layers of surface water, photo-induced degradation of B[a]P may occur yielding a substance that is toxic for aquatic organisms. There is no need to include exposure considerations since this is not relevant for the identification as SVHC. Furthermore, the T criterion is already fulfilled due to B[a]P’s harmonised classification as CMR.

Minor remarks

We agree that the opening sentence is too generic and should be changed to “… some substances of this group have already been proven to be hazardous for humans and the environment”.

Additionally, we agree to add the synonyms Benzo-alpha-pyrene as well as 3,4-Benzopyrene and 4,5-Benzochrysene to Table 1 and included the boiling point at atmospheric pressure in Table 2.

We finally would like to point out that the formal procedure for identifying SVHCs under REACH foresees no further commenting period. Therefore, there will be no second opportunity for commenting on the SVHC dossier.

PART II

The information provided in part II is relevant for the process of prioritisation for Annex XIV. Therefore the information you provided can be used later in this process.

4604
2016/04/14	DEZA, a.s.,
Company,
Czech Republic	The proposal assess another substance (CTPHT), not benzo(a)pyrene. We suggest to return the proposal to submitter for update	This is a misunderstanding. The SVHC proposal uses an already agreed assessment of B[a]P’s PBT and vPvB properties as presented within the SVHC identification of CTPHT. 	
4607
2016/04/14	ANSES,
Academic institution,
France	Minor comment : In page 12, section 3.1.2 Biodegradation, 3.1.2.1.1  Estimated data

There is a little mistake in the half-lives values of the substance in the sediments, the range presented in the report corresponds to the soil compartment. According to the document of risk assessment of CTPHT  (page 77), the half- lives values in the sediments can be estimated more than 1250 days.	Thank you for the comment. The issue has been revised and amended accordingly.	
4610
2016/04/14	Health and Environment Alliance (HEAL),
International NGO,
Belgium	HEAL supports the nomination of this substance as an SVHC.	Thank you for your support.	

Specific comments on the justification

Number / Date	Submitted by (name, submitter type, country)	Comment	Responses	
4582
2016/04/12	Norway,
Member State	The Norwegian CA supports that benzo[a]pyrene (B[a]P) should be identified as a substance of very high concern (SVHC) and should be included in the Candidate List.

The Norwegian CA agrees that scientific evidence shows that B[a]P fulfills the criteria in REACH Article 57 a), b), c), d) and e) since the substance is classified as Carc. 1B, Muta 1B and Repr. 1B, and fulfills the criteria in REACH Annex XIII, i.e. is PBT/vPvB. B[a]P degrades very slowly in soil with half-lives > 180 days (P/vP), BCFs > 5000 (B/vB) in invertebrates and the substance is very toxic (T).

A large amount of data on B[a]P in different matrixes are available from Norwegian monitoring studies. These reports can be available on request.	Thank you for your support.	
4591
2016/04/14	ChemSec,
International NGO,
Sweden	ChemSec supports the identification of benzopyrene as an SVHC based on the whole range of hazardous properties described in the dossier. The official classification leaves no doubt and the presented evidence makes a clear case also for the PBT/vPvB properties.	Thank you for your support.	
4595
2016/04/14	Concawe,
Industry or trade association,
Belgium	Concawe has several comments on Part I of the Annex XV report that are all captured in the attached document. When needed for the ease of processing these, a Word-version of this can be made available that will not replace this.	See comments above concerning comment no. 4595.	
		See attachments under General comments:
4595_B(a)P SVHC proposal dossier Concawe comments - final 20160414.pdf		
4596
2016/04/14	Netherlands,
Member State	NL supports the proposal to include BaP in the candidate list of SVHC in accordance with Article 57(a to e) of Regulation (EC) 1907/2006 (REACH) due to its CMR, PBT and vPvB properties which may cause serious effects to human health and to the environment.	Thank you for your support.	
4599
2016/04/14	CHEM Trust,
National NGO,
United Kingdom	CHEM Trust supports inclusion of Benz-a-pyren in the REACH  candidate list based on its carcinogenic properties.	Thank you for your support.	
4604
2016/04/14	DEZA, a.s.,
Company,
Czech Republic	Germany as a submitting member state self-classify the substance as PBT and/or vPvB and therefore fulfilling the criteria in Article 57 d) and e) of Regulation 1907/2006 (REACH) and completely ignoring the judgement of the General Court in the case T-689/13 stating that European Commission made “manifest error of assessment”. We suggest to delete the whole section “Article 57 (d) – (e) on page 6 of the document and remove the classification as Aquatic Acute 1 (H400) and Aquatic Chronic 1 (H410) from Table 3 on page 10. There was no scientific assessment of environmental and PBT/vPvB properties of the substance benzo(a)pyrene at all.
However, we agree, that the substance benzo(a)pyrene meets the criteria according to Article 57 a) b) and c), so the substance can be included in Candidate List due to CMR properties, as mentioned in the document.
We disagree with proposed approach how to generate and assess the data on environmental fate of the substance. Again, we would like to refer to the judgement in case T689/13 stating that there was “manifest error of assessment”.	The judgment of the General Court in the case T-689/13 (currently under appeal), relates to the classification for environmental effects of a different substance, namely, pitch, coal tar, high-temperature. Therefore it is not relevant to consider a court case on a different substance in the context of this SVHC proposal for benzo[a]pyrene. 
	
		-		
4607
2016/04/14	ANSES,
Academic institution,
France	Benzo[def]chrysene (CAS name: Benzo[a]pyrene, B[a]P)  belongs to the substance group of
Polycyclic Aromatic Hydrocarbons (PAHs).  Information about their PBT or vPvB properties has been well documented. The proposal for identification of this substance as SVHC is mainly based on information from the evaluation of PBT/vPvP properties carried out by the MS in the context of the identification of CTPHT  as SVHC.

According with all data presented in the report, the substance fulfills the PBT and vPvB criteria of  REACH Annex XIII:

-  Experimental data allows to classify B[a]P as persistent (P) and very persistent (vP) for the soil compartment exhibiting a DT50 >180 days. Estimation models also indicate the potential persistence behavior of the substance in water and sediment compartments.

- Very high BCFs values were reported in the literature, the most sensitive’s species are those lacking Cytochrome P450 enzymes , until 140700 L/Kg (5% lipids) was reported for Dreissene Polyforma (Gossiaux et al., 1996). According to experimental data B[a]P  fulfills  B and vB criteria (BCF>5000)

- Several studies have been reported about the ecotoxicity of B[a]P, as already discussed in the document, UV radiation increases toxicity of B[a]P. The lowest value reported in long term studies exposed with UV radiation was on shell development of the marine mollusk Crassostrea gigas exhibiting an EC10 of 0.22µg/L (Lyons et al., 2002).  Considering this value the substance fulfils the T criteria (EC10<0.01mg/L).
Furthermore, the substance is classified as:
Carcinogenic category 1B
Germ cell mutagenicity category 1B
Reproductive toxicity category 1B

Taking into account all these information, ANSES supports the SVHC proposal.	Thank you for your support.	
		-		
4615
2016/04/25	Finland,
Member State	The Finnish CA agrees that benzo[def]chrysene (benzo[a]pyrene, B[a]P)(EC 200-028-5) as a substance meets the criteria in Article 57(a)(Carc. 1B), Article 57(b) (Muta. 1B), Article 57(c)(Repr. 1B), Article 57(d)(PBT) and Article 57(e) (vPvB) and can thus be identified as a substance of very high concern (SVHC).

The Annex XV report for B[a]P is based on data for B[a]P presented in the Support Document for the identification of CTPHT and in the EU Risk Assessment Report on CTPHT (European Commission, 2008). The Finnish CA notes that no Risk Management Option Analysis (RMOA) conclusion document has been published on the ECHA website.

As there are no registrations for B[a]P, the Finnish CA assumes that the substance will be of low priority for inclusion to Annex XIV. The main consequence of an inclusion to the candidate list would therefore be related to articles containing B[a]P. The Finnish CA notes that the use of PAH compounds, including B[a]P, for treatment of wood, in tyres and in certain consumer articles has already been restricted by REACH (Annex XVII entries 31 and 50).

The Finnish CA notes further that B[a]P is almost never produced intentionally but rather occurs ubiquitously as a by-product or an impurity in other substances. According to the Annex XV dossier, at least 266 substances registered by the end of 2014 could possibly contain B[a]P but it was only mentioned as a constituent in 164 registration dossiers for 29 different UVCB substances (as of 19th January 2016).

The authorisation requirement applies, however, to the placing on the market and use of a substance on its own as listed in Annex XIV. Therefore, it usually does not apply if the Annex XIV substance is only an impurity or additive or constituent of another substance, unless this is specified in the Annex XIV entry.

Therefore, the purpose and scope of the proposed entry "benzo[def]chrysene (benzo(a)pyrene)(EC 200-028-5)(CAS 50-32-8) is unclear. Is it intended to cover also substances that contain B[a]P as a impurity or constituent?

The Finnish CA considers that after a potential inclusion of the substance in the candidate list (for eventual inclusion in the Annex XIV) it can still be further explored which risk management measures would be the most appropriate.
	Thank you for your comment. The SVHC identification of B[a]P serves as a first step for the following regulatory actions for this substance. The German CA sees a special need to clearly identify the PBT and vPvB properties of B[a]P as diverging views are present in industry.

The RMOA has been prepared by DE in 2011 and has been commented by MS. 

The current proposal is intended to cover the substance as such (EC 200-028-5; CAS 50-32-8) and does not propose to cover other substances that contain B[a]P as an impurity or constituent.

Which next steps are needed to come to an acceptable regulation of the risk derived from B[a]P and other PAHs will have to be decided at a later stage and should also reflect the results of the work of the PetCo-Working group. As such, your remarks concerning the best regulatory strategy are valuable and will be considered at a later point in time.

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, submitter type, country)	Comment	Responses	
4585
2016/04/12	Mineralölwirtschaftsverband,
Industry or trade association,
Germany	On page 26 the statement is made that “It should be mentioned that sources of PAHs, which are outside the scope of REACH, such as combustibles, motor fuels, or emissions from combustion plants, are relevant in terms of used amounts as well. Combustibles and motor fuels are explicitly excluded from the regulation…Nevertheless, exposure to B(a)P as a result of the uses of B(a)P- containing substances as mentioned above poses a potential risk for the environment and human health that could (and therefore should) be reduced…”

This statement invariably leads the reader to the conclusion that all – or at least the majority of - combustibles and motor fuels contain B(a)P in considerable amounts and thus lead to exposure.  This conclusion is in opposition to facts.

For explanation, it needs to be mentioned that Polycyclic Aromatic Hydrocarbons (PAH) like B(a)P are contained naturally occurring constituent (in minor concentrations) of crude oils. Processing of crude oil into valuable products primarily consists of distillation – separation of substances contained in the crude according to their boiling point. As is documented in the substance identification part of registration dossiers, combustibles and motor fuels petroleum gases, gasolines, kerosines and MK1 diesel fuel contain hydrocarbons with boiling point below 320°C. Since B(a)P boiling point is about 460°C (at atmospheric pressure), B(a)P concentrations in these fuels are below detection limits. Even diesel fuel and domestic heating oil (gasoils), stating boiling point range of their constituents “up to 500°C” show negligible content of B(a)P (source: DGMK Report 583 “composition of diesel fuels from German refineries”, 2002).  These findings are currently confirmed in the actual Concawe Analytical project that only found one Diesel fuel component with a B(a)P content above 10 ppm (mg/kg).

The assumption mentioned in paragraph 1 is therefore proven false, the wording leading to it needs to be removed from the report.  Therefore, in case B(a)P is measured in automotive exhaust emissions this is due to the combustion process itself and the ill functioning of the car engine and its catalytic converters that are not the responsibility of refining sector.

In light of this, also the statement on page 26 “According to our own screening, at least 266 substances registered by the end of 2014 could possibly contain B(a)P …” is to be treated with caution. Since no screening criteria are given in this document, it is quite probable that a majority of the 266 substances stated above likewise is falsely assumed to contain B(a)P.

Same time, the stated risks from use of products containing B(a)P as indicated by the last paragraph on page 26 seem to be overstated. As is rightly pointed out in chapter 8, use is restricted to industrial and professional uses, where appropriate safety measures (i.e. full body protection and life support while working in B(a)P containing equipment)  are taken. For most products, no risk can be specified due to the fact that B(a)P has high boiling point and very low volatility, thus is immobilized within the matrix of the product and not bio-available. As an example, a recent Concawe report has analyzed risk to employees from vapors emitted during hot loading of heavy fuel oil on barges (Concawe report 1/15R, 2015). Conclusion of the report is that there is no significant health risk.

Chapter 9 on Page 29 states, “The main reason for the further use of substances containing problematic PAHs seems to be an economical one”. This statement is highly misleading since it implies a choice being taken by producers or users to add B(a)P willingly to the product. In contrast, on page 26 it is rightly stated that “B(a)P is almost never produced intentionally…”. As pointed out above, it is contained as an impurity already in the crude oil. Due to the boiling point of B(a)P, it is not contained in the refinery streams that are used to produce automotive and aviation fuels.

An attempt to reduce its concentration in products is successful only in special cases –like with extender oils for tires, where low-aromatic oils were available as alternative. As yet, no processing technique is known to selectively extract B(a)P from a given UVCB. Similarly, the attempt to destroy B(a)P thermally within the product  typically yields other carcinogenic compounds. An attempt to prescribe complete avoidance of B(a)P in all products thus needs to be seen critically.

A general observation of the DRAFT SVHC report is that it blindly follows the conclusions of the Coal Tar Pitch High Temperature Risk Assessment Report that was compiled under Existing Substances Regulation.  This report is mainly based upon data that compiled in the previous century (pre-2001).

One has to perform a thorough literature review on any new data and insights that have been developed and published, since. As this is absent in this report, it is difficult to accept that it should cover these latest insights. In our perception up-to-date knowledge does not render B(a)P to be neither a PBT nor a vPvB. It is advised that the authors will rework their report to include these scientific developments and draw their conclusions accordingly.

Today, the report clearly expresses a pre-positioned attitude that falsely assumes high expositions and easy-to-use measures to further reduce the B(a)P content in all products, which is not supported by reality.	Your comments on part II of the SVHC proposal will be taken into account during prioritisation procedures for inclusion in Annex XIV.

Concerning your comment on the age of the studies cited and the general PBT assessment please see our response to comment no. 4595 above.	
		-		
4595
2016/04/14	Concawe,
Industry or trade association,
Belgium	Concawe has several comments on Part I of the Annex XV report that are all captured in the attached document. When needed for the ease of processing these, a Word-version of this can be made available that will not replace this.	Please see our response to comment no. 4595 above.	
		See attachment under General comments: 
4595_B(a)P SVHC proposal dossier Concawe comments - final 20160414.pdf		
4596
2016/04/14	Netherlands,
Member State	In addition, the NL-CA commented on the RMOA that a targeted restriction would be more adequate, because:
- A restriction can be targeted to the applications causing a risk, whereas an authorisation applies to all uses. The potential risk reduction capacity of both instruments is considered to be the same. A targeted restriction is however more proportionate to the risk than the general authorisation demand.
- In our view the expected workload for both industry and authorities for authorisation route would be huge given the large amount of applications. This aspect is recognized in the RMO analysis, but in your view speculative. Of course the exact amount of application requests from industry is unknown, but in our view inclusion in Annex XIV will most likely result in a large number of authorisation requests. It is also important to keep in mind that an authorisation will be granted for a limited period of time, so after several years industry has to submit new requests.
- Preparing an Annex XV restriction dossier will of course take more time than preparing an Annex XV SVHC dossier. However much time and effort will be saved later in the process, because RAC and SEAC will only have to consider one dossier and after the restriction has been adopted no further involvement of RAC and SEAC is required. Also the efforts from industry will be much lower for the restriction route.
- Imported articles are excluded from authorisation and therefore additional to the inclusion of BaP into Annex XIV a restriction might be needed for these articles. It seems more efficient to opt for a restriction dossier from the start.
- In this case with many applications, enforcement of a targeted restriction seems to be easier than the enforcement of authorisation applications because for restrictions the same conditions and timelines apply for all companies, whereas the conditions in authorisation decisions are applicant specific.	Thank you for your comment. The SVHC identification of B[a]P serves as a first step for the following regulatory actions for this substance. The German CA sees a special need to clearly identify the PBT and vPvB properties of B[a]P as divergent views are present in industry.

The RMOA has been prepared by DE in 2011 and has been commented by MS.

Which next steps are needed to come to an acceptable regulation of the risk derived from B[a]P and other PAHs will have to be decided at a later stage and should also reflect the results of the work of the PetCo-Working group. As such, your remarks concerning the best regulatory strategy are valuable and will be considered at a later point in time.
	
		-		
4604
2016/04/14	DEZA, a.s.,
Company,
Czech Republic	The document state that there is no manufacture of the substance benzo(a)pyrene in European Union. This information is not true. Every European citizen including submitters of SVHC proposal manufacture some amount of benzo(a)pyrene. Whether this manufacture is intentional or not is another question. All the manufactured quantity goes directly to environment, so there are no uses of the substance as such (only one use could be considered – use in laboratories as positive control).	To further clarify how the term “manufacturing” was used in the SVHC dossier, we like to refer you to the definitions of “manufacturing” and “manufacturer” as provided in article 3 of the REACH regulation.