EN    EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
D039202/01  
[…](2015) 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 inorganic ammonium salts  
(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 inorganic ammonium salts  
(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/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
68(1) thereof,  
Whereas:  
(1) On 14 August 2013, in accordance with the safeguard clause in Article 129(1) of 
Regulation (EC) No 1907/2006, the French Republic informed the Commission, the 
European Chemicals Agency (‘the Agency’) and the other Member States that it ha d 
adopted a provisional measure on 21 June 20132 to protect the public from exposure to 
ammonia released from cellulose wadding insulation materials with ammonium salts  
used in buildings .  
(2) The provisional measure was authorised until 14 October 2016 by Commission 
Implementing Decision 2013/505/EU3, adopted  under  Article 129(2) of Regulation 
(EC) No 1907/2006 . 
(3) In accordance with Art icle 129(3) of Regulation (EC) No 1907/2006, the French 
Republic initiated the  restriction procedure  by submitt ing to the Agency an Annex XV 
dossier  on 18 June 2 014.  
(4) The Annex XV dossier4 propose d a restriction on inorganic ammonium salts, which 
are added  to cellulose insulation as flame retardant s, since they lead to the emission of 
                                                 
1 OJ L 396, 30.12.2006, p 1.  
2 Journal Officiel de la République Française , 3 July 2013, "Order of 21 June 2013 on the prohibition to 
place on the market, import, sell, distribute or manufacture cellulose wadding insulation materials with 
ammonium salts additives".  
3 Commission Implementing  Decision of 14 October 2013 authorisi ng the provisional measure taken by 
the French Republic in accordance with Article 129 of Regulation (EC) No 1907/2006 of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of 
Chemicals (REACH)  to restrict the use of ammonium salts in cellulose wadding insulation materials 
(OJ L 275, 16.10.2013, p. 52 ).  
4 http://echa.europa.eu/documents/10162/999a106c -6baf-48c7 -8764 -0c55576a2517    
EN 3   EN ammonia gas u nder certain conditions.  The dossier propose d 3 ppm as a limit for the 
emission of ammonia from cellulose insulation treated with inorganic ammonium 
salts, rather than setting a limit for the content of ammonium salts in the cellulose 
insulation . The dossier demonstrated that action on a Union -wide basis is necessary.  
(5) On 3 March 2015, the Agency's Committee for Risk Assessment  ('RAC ') adopted an 
opinion  on th e restriction proposed in the Annex XV dossier, con cluding  that there is a 
risk to human health due to the release of ammonia from cellulose insulation mixtures 
and articles that needs to be addressed. RAC further stated that the proposed 
restriction, as modified  by RAC , is the most appropriate Union -wide measure to 
address the identified risks in terms of the effectiveness in reducing th ose risks.  
(6) RAC proposed that the restriction cover  the placing on the market of cellulose 
insulation  containing inorganic ammonium salts, in both mixture  and article form .  
RAC recommended  that the restriction oblige  suppliers  of cellulose insulation 
mixtures to communicate down the supply chain and ultimately to  end users, the 
maximum loading rate5 of th e cellulose insulation mixture used in the test  done prior 
to market ing to demonstrate compliance , in particular through documentation 
accompanying the mixtures  or through labelling . The restriction should also require  
that the maximum loading rate is resp ected when the cellulose insulation mixtures are 
used, so that ammonia emissions will not exceed the level determined  in the pre -
market test.  RAC also recommended that b y way of derogation , cellulose insulation 
mixtures which are only used for the production  of cellulose insulation articles do not 
have to comply with the limit set for the emission of ammonia , as the resulting article 
must itself compl y with the emission limit when it is placed on the market or used .  
(7) On 10 June 2015, the Agency's Co mmittee for Socio -Economic Analysis ('SEAC') 
adopted an opinion on the restriction proposed in the Annex XV dossier , indicat ing 
that the proposed restriction, as modified  by SEAC , is the most appropriate Union -
wide measure to address the identified risks in terms of the proportionality of its socio -
economic benefits to its socio -economic costs.    
(8) SEAC concluded that two years , rather than the one year  proposed in the Annex XV 
dossier , should be given to  economic operators to allow them sufficient time to ensure 
that emission s of ammonia from cellulose insulation containing inorganic ammonium 
salts are below the specified emission limit.  
(9) RAC and SEAC agreed with the French Republic that a n exemption for cellulose 
insulation treated with inorganic ammonium s alts for outdoor use  should not be 
granted .  
(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 25 June 2015  the Agency submitted the opinions of RA C and SEAC6 to the 
Commission. B ased on those opinions, the Commission concluded that an 
unacceptable risk to hu man health arises from  cellulose insulation treated with 
inorganic ammonium salts where the emission  of ammonia reaches or exceeds  a 
concentration  greater  than 3 ppm  under the specified test conditions .  
                                                 
5 The loading rate of the cellulose insulation  (stated e.g. in kg/m2) is expressed in  thickness ( stated  e.g. in 
m) and density ( stated  e.g. in kg/m3). 
6 http://echa.europa.eu/documents/10162/522a9f94 -058a -4bef-9818 -f265a1d2d64d    
EN 4   EN (12) No specific method for the measurement of the emission of ammonia from cellulose 
insulation treated with inorganic ammonium salts is presently available . Therefore, an 
existing test method , Technical Specification CEN/TS 16516 , should be adapted  for 
use in determining compliance with the restriction  on inorganic ammonium salts  until 
a dedicated method is developed .   
(13) Stakeholders should be allowed sufficient time to take appropriate measures to ensure  
that, if inorganic ammonium salts are used in cellulose insulation , ammonia  emission s 
do not exceed  the specified limit . The application of the restriction on inorganic 
ammonium salts  should therefore be deferred . However, in the interes ts of continuity 
and legal certainty, the restriction should apply immediately on entry into force  of this 
Regulation in a Member State which  already has in place national  measures restricting 
ammonium salts in cellulose insulation that have been authorise d by the Commission 
in the context of the REACH safeguard procedure . 
(14) Regulation (EC) No 1907/2006 should th erefore be amended accordingly.  
(15) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee established under Ar ticle 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