EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2016) XXX  draft  
  
COMMISSION REGULATION (EU) …/…  
of XXX  
amending Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards bisphenol A  
(Text with EEA relevance)   EN 2   EN COMMISSION REGULATION (EU) …/…  
of XXX  
amending  Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament 
and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH) as regards bisphenol A  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union,  
Having regard to Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission 
Directives 91/155/E EC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1) thereof,  
Whereas:  
(1) On 6 May  2014 , France  submitted to  the European Chemicals Agency (‘the Agency’) 
a dossier pursuant to Article 69(4) of Regulation (EC) No 1907/2006  (‘the Annex XV 
dossier’2), in order to initiate the restriction procedure set out in Articles 69 to 73 of 
that Regulation.  The Annex XV dossier indicated a risk for workers (primarily 
cashiers) and consumers exposed to bisphenol A (BPA) by handling therma l paper  
receipts  and proposed a restriction on the placing on the market of BPA  in thermal 
paper  in a concentration equal to or greater than 0.02% by weigh t. 
(2) Thermal paper is composed of a base paper coated  with at least one chemical layer  
which may contai n BPA . The coating changes colour when exposed to heat, allowing 
the printed characters to appear.  
(3) France  based its hazard assessment of BPA on the effects on several human health 
endpoints (the female reproductive system, the brain and behaviour, the mammary 
gland, metabolism and obesity) . The effects on the mammary gland were considered 
the most critical endpoint , prevailing over the others . They were used to calculate the 
Derived No Effect Level (DNEL).  
(4) During the opinion form ing process  of the Agency , the European Food Safety 
Authority (EFSA) published a new scientific opinion on BPA3. The Agency’s 
Committee for Risk Assessment ( RAC ) discussed the assessment  of BPA with EFSA 
in order to ensure consistency in the scientific evaluation and to base it on the most 
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2 http://echa.europa.eu/documents/10162/c6a8003c -81f3-4df6-b7e8 -15a3a36baf76  
3 http://www.efsa.europa.e u/en/efsajournal/pub/3978  EN 3   EN recent and updated scientific literature.  The hazard assessment of RAC, as presented in 
its opinion, is consistent with the approach used by  EFSA.  
(5) RAC considered that the critical studies selected by France  to calculate the DNEL did  
not allow quantification of the dose -response relationships and showed uncertainties. 
Therefore, f or the purposes of calculating an oral DNEL, RAC selected the effects on 
the kidney and, as the available data indicated that kidney effects are not the most  
critical effects of BPA, applied an additional assessment factor of 6  to take account of 
the other endpoints in the overall hazard assessment. Since the restriction proposal 
concerns the dermal route of exposure due to handling thermal paper, a  DNEL for t he 
dermal exposure route was also calculated for workers and the general population . As 
regards exposure , RAC refined the assessment and complemented it with new 
biomonitoring information on cashiers’ exposure to BPA. A pplying  this methodology , 
RAC conclud ed that the risk for consumers is adequately controlled but confirmed the 
risk for workers.  
(6) On 5 June 2015 , RAC  adopted its opinion  and considered the proposed restriction to 
be the most appropriate Union -wide measure to address the identified risks in terms of 
effectiveness in reducing th ose risks.  
(7) Pursuant to the conclusion of RAC that the available data did not allow a 
quantification of the dose -response relationship for the health effects of BPA,  the 
Agency's Committee for Socio -Economic Analysis  (‘SEAC ’) could not use the benefit  
estimates presented in the French dossier  and t hus performed a break-even analysis , 
upon which it concluded that  overall the estimated costs outweigh the potential health 
benefits of the proposed restriction . However , SEAC n oted that the cost of the 
restriction amounts to a  very small proportion of the total personnel costs or gross 
operating surplus of the affected sectors in the Union , and to a very small price 
increase if transferred to consumers through increased prices of consumer goods. 
Furthermore, SEAC noted that the restriction may lead to a more equitable distribution  
of impacts , considering that the sub-population of cashiers potentially at risk is 
disproportionately affected by the adverse health impacts , whereas the economic 
impact would be evenly shared by the wider Union population.  
(8) On 4 December  2015, SEAC adopted its opinion  and considered  the proposed 
restriction unlikely to be proportionate in terms of comparing its socio -economic  
benefits to its socio -economic costs,  but highlighted  possibl e favourable distributional 
and affordability considerations . Furthermore, SEAC confirmed that a Union wide 
measure is justified and concluded that the proposed restriction cannot be rejected as 
an approp riate measure to address the human health risks to workers.  
(9) RAC and SEAC also concluded that the proposed restriction is implementable, 
enforceable, manageable and monitorable.  
(10) The Agency's Forum for Exchange of Information on Enforcement was consulted 
during the restriction process and its recommendations were taken into account.  
(11) On 29 January 2016 , the Agency submitted the opinions of RAC and SEAC4 to the 
Commission. B ased on those opinions, the Commission concluded that there is an 
unacceptable risk to the health of workers who handl e point of sale receipts made of 
thermal paper containing BPA  in a concentration equal to or greater than  0.02% by 
                                                 
4 http://echa.europa.eu/documents/10162/9ce0977b -3540 -4de0 -af6d-16ad6e78ff20  
 EN 4   EN weight.  Taking into account SEAC's considerations on affordability and distributional 
effects, the Commission  considers that the proposed restriction would address the 
identified  risks  without imposing  significant burden on industry, supply chain or 
consumers . Thus, the  Commission concluded that the restriction proposed by France  is 
an appropriate Union wide meas ure to address the identified risk s to the health  of 
workers who handle point of sale receipts made of thermal paper containing BPA.  By 
regulating the placing on the market, the proposed restriction would also provide a 
greater margin of protection for co nsumers.  
(12) Since t est methods to measure the concentration of BPA in thermal paper are currently 
available  the restriction  is enforceable.  As confirmed by SEAC, the application of the 
restriction should be deferred in order  to enable industry to comply  with it. A period of 
36 months seems reasonable and sufficient for that purpose.  
(13) In its opinion, RAC noted that bisphenol S (BPS), the most likely substitute according 
to France , may have a toxicological profile similar to BPA and might cause similar 
adverse h ealth effects. Therefore , in order to avoid that the adverse effects of BPA 
would simply be supersed ed by the adverse effects of BPS  particular attention should 
be paid to an eventual substitution trend towards BPS. To that end, the Agency  should 
monitor a ny substance evaluation decision on BPS under the Community Rolling 
Action Plan . The Agency should communicate  any further information to the 
Commission so that it consider s whether a proposal to restrict BPS under Regulation 
(EC) No 1907/2006 is necessary  given that, contrary to BPA, the health risk associated 
to BPS has not yet been sufficiently established .  
(14) Regulation (EC) No 1907/2006 should therefore be amended accordingly . 
(15) The measures provided for in this Regulation are in accordance with the opinio n of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006 , 
HAS ADOPTED THIS REGULATION:  
Article 1  
Annex XVII to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to 
this Regulation.  
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union . 
This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Jean -Claude Juncker