EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2019) XXX  draft  
ANNEX  
 
ANNEX  
to the  
Commission Delegated Regulation  
amending Regulation (EC) No 1272/2008 of the European Parliament and of the Council 
on classification, labelling and packaging of substances and mixtures as regards 
information relating to emergency health response   EN 1  EN ANNEX  
Annex VI II to Regulation (EC) No 1272/2008 is amended as follows:  
(1) Part A is amended as follows:  
(a) Section 1.1 is replaced by the following:  
‘1.1 Importers and downstream users placing on the market mixtures for consumer 
use, within the meaning of Section 2.4 of Part A of this Annex, shall comply with 
this Annex from 1 January 2021. ’;  
(b) Section 2.3 is replaced by the following:  
‘ 2.3. In the cas e of mixtures placed on the market for industrial use only, 
submitters may opt for a limited submission, as an alternative to general submission 
requirements, in accordance with Section 3.1.1 of Part B, provided that a rapid access 
to additional detailed p roduct information is available in accordance with Section 1.3 
of that Part.’; 
(c) Section 4.1 is replaced by the following:  
‘ 4.1 A single submission, hereinafter 'group submission', may be provided 
for more than one mixture where all the mixtures in a group  have the same 
classification for health and physical hazards .’; 
(d) Section 4.3. is replaced by the following:  
‘ 4.3. By way of derogation from Section 4.2, a group submission shall also 
be allowed where the difference in the composition between different mixtures in the 
group only concerns perfumes, provided that the total concentration of the differing 
perfumes contained in each mixture  does not exceed 5 %.’; 
(e) in Section 5.1, the third subparagraph is replaced by the following :  
‘ By way of derogation from the second subparagraph, a new UFI shall not be 
required for mixtures in a group submission containing perfumes  provided that the 
change in the composition only concerns those perfumes or the additi on of new 
perfumes .’; 
(f) Section 5.2 is replaced by the following:  
‘ 5.2.  The submitter shall print or affix the UFI on the label of the hazardous 
mixture or, alternatively,  on the packaging in close pro ximity to the label.  
In the case of mixtures which are not packaged, the UFI shall be indicated in the 
Safety Data Sheet or be included in the copy of the label elements referred to in 
Article 29 (3), as applicable .  
The UFI shall be preceded by the acronym "UFI" in capital letters followed by a 
colon (“UFI:”) and it shall be clearly visible, legible and indelibly marked. ’; 
(g) Section 5.3 is replaced by the following:  
‘ 5.3 By way of derogation from the first subparagrap h of Section 5.2 , in the 
case of mixtures supplied  for use at industrial sites, the UFI may alternatively be 
indicated in the Safety Data Sheet .’;  
(2) Part B is amended as follows:  
(a) in Section 1.1, the second subparagraph is replaced by the following:  EN 2  EN ‘The complete trade name(s) of the mixture shall be provided, including, where 
relevant, brand name(s), name of the product and variant names as they appear on the 
label, without abbreviations and enabling its specific identification. ’;  
(b) Section 1.2 is replaced  by the following:  
‘ 1.2. Details of the submitter and contact point  
The name, full address, telephone number and e -mail address of the submitter shall 
be provided  and, if different, the name, full address, telephone number and e -mail 
address of the point of contact to be used for obtaining further information relevant 
for emergency health response purposes .’;  
(c) Section 1.3  is replaced by the following:  
‘ 1.3. Telephone number and e -mail address for rapid access to additional 
product information   
In the case of a limited submission as laid down in Section 2.3 of Part A, a telephone 
number and an e -mail address shall be provided at which rapid access to detailed 
additional product information relevant for emergency health response purposes is 
available  in the language provided in Section 3.3 of Part A . The telephone number 
shall be accessible 24 hours  per day, 7 days  per week.’ ; 
(d) in Section  2.4, the third indent is replaced by the following:  
‘ – the pH , if available, of the mixture as supplied, or , where the mixture  is 
a solid, the pH of an aqueous liquid or solution at a given concentration. The 
concentration of the test mixture in water shall be indicated . If the pH is not 
available, the reasons  shall be given ;’ 
(e) in Section 3.1, the third and fourth subparagraphs are replaced by the following:  
‘  By way of derogation from the second subparagraph, in a group submission, 
perfume components in mixtures shall be present in at least one of the mixtures.  
For group submissions where the perfumes vary between the mixtures contained in 
the group, a list shall be provided of the mixtures and the perfumes they contain, 
including their classification. ’; 
(f) Section 3.1.1 is replaced by the following:  
‘ 3.1.1.  Requirements for mixtures for industrial use  
In the case of a limited submission as laid down in Section 2.3 of Part A, the 
information to be submitted on the composition of a mixture for industrial use may 
be limited to the information contained in the Safety Data Sheet in accordance with 
Annex II to Regulation (EC) No  1907/2006, provided that additional information o n 
the composition is  available on request for rapid access  in accordance with 
Section  1.3.’; 
(g) the heading to Section 3.2 is replaced by the following:  
‘ Identification of mixture components ’; 
(h) in Section 3.2, the following paragraph is inserted before Section 3.2.1:  
‘ A mixture component  is either a substance or a mixture in mixture.’ ; 
(i) in Section 3.2.2 , the second subparagraph is replaced by the following:  EN 3  EN ‘Information on the substances contained in a MIM shall be provided in accordance 
with the criteria of Section 3.2.1, unless the submitter does not have access to 
information on the full composition of the MIM. In the latter case, the MIM shall be 
identifie d by means of its product identifier in accordance with Article 18(3)(a), 
together with its concentration and UFI, if available and if the appointed body has 
received the information on the MIM in a prior submission. In absence of a UFI or if 
the appointed  body has not received the information on the MIM in a prior 
submission, the MIM shall be identified by means of its product identifier in 
accordance with Article 18(3)(a), together with its concentration and the 
compositional information contained in the Safety Data Sheet of the MIM and any 
other known components, as well as the name, e -mail address and telephone number 
of the MIM supplier. ’; 
(j) Section 3.2.3 is replaced by the following:  
‘ 3.2.3. Generic product identifiers  
By way of derogation from Sectio ns 3.2.1 and 3.2.2, the generic product identifiers 
“perfumes ” or “colouring agents” may be used for mixture components used 
exclusively to add perfume or colour, where the following conditions are met:  
– the mixture components are not classified for any he alth hazard,  
– the concentration of mixture components identified with a given generic 
product identifier does not exceed in total:  
(a) 5 % for the sum of perfumes; and  
(b) 25 % for the sum of colouring agents. ’; 
(k) Section 3.3 is replaced by the following:  
‘ 3.3. Mixture components subject to submission requirements  
The following mixture components shall be indicated:  
(1) mixture components classified as hazardous on the basis of their health or 
physical effects which:  
– are present in concentrations equal to or greater than 0.1  %; 
– are identified, even if in concentrations lower than 0.1  %, unless the submitter 
can demonstrate that those components are irrelevant for the purposes of 
emergency health response and preventative measures;  
(2) mixture components not classified as hazardous on the basis of their health or 
physical effects which are identified and present in concentrations equal to or 
greater than 1 %.’; 
(l) Section 3.4 is replaced by the following:  
‘ 3.4. Concentration and concentrat ion ranges of the mixture components  
Submitters shall provide the information laid down in Sections 3.4.1 and 3.4.2 with 
regard to the concentration of the mixture components, identified in accordance with 
Section 3.3. ’; 
(m) in Section 3.4.1 , the title of Table 1  is replaced by the following:  
‘Concentration ranges applicable to hazardous components of major concern for 
emergency health response ’; EN 4  EN  
(n) Section 3.4.2 is replaced by the following:  
‘ 3.4.2.  Other hazardous components  and components not classifie d as 
hazardous  
The concentration of the hazardous components  in a mixture that are not classified 
for any of the hazard categories listed in Section 3.4.1 and of the identified 
components not classified as hazardous shall be expr essed, in accordance with 
Table 2, as ranges of percentages in descending order by mass or volume. As an 
alternative, exact percentages may be provided.  
By way of derogation from the first subparagraph, for perfume components that are 
not classified or only classified for skin sensitisation Category 1, 1A or 1B or 
aspiration toxicity, submitters shall not be required to provide information on their 
concentration, provided that their total concentration does not exceed 5  %. 
 
Table 2  
Concentration ranges applicable to other hazardous components and  
components not classified as hazardous  
 
Concentration range of the 
component contained in the mixture 
(%) Maximum width of the 
concentration range to be used 
in the submission  
≥ 25 - < 100 20 % units  
≥ 10 - < 25 10 % units  
≥ 1 - < 10 3 % units  
>0 - < 1 1 % units ’; 
 
(o) Section 3.5 is replaced by the following:  
‘ 3.5. Class ification of mixture components  
The classification of mixture components for health and physical hazards (hazard 
classes, hazard categories and hazard statements) shall be provided. This includes the 
classification for at least all substances referred to in Point 3.2.1 of Annex II to 
Regulation (EC) No 1907/2006 on requirements for the com pilation of Safety Data 
Shee ts. In the case of a MIM identified by means of its product identifier and its UFI 
in accordance with Section 3.2.2. of Part B, only the classification for health and 
physical hazards of the MIM shall  be provided.’ ; 
(p) in Section 4.1, the title of Table 3 is replaced by the following:  
‘Variations of the concentration of components requiring a submission update ’; 
(q) in Section 4.1, the final subparagraph is replaced by the following:  
‘When the perfumes in a group submission change, the list of mixtures and the 
perfumes they contain as required in Section 3.1. shall be updated.’ ;  
(3) Part C is amended as follows : EN 5  EN (a) Section 1.2 is replaced by the following:  
‘1.2. Identification of the mixture and of the submitter  
Product identifier  
– Complete trade name(s) of the product (in case of group submission, all 
product identifiers shall be listed)  
– Other names, synonyms  
– Unique Formula Identifier(s) (UFI)  
– Other identifiers (authorisation number, company product codes)  
Contact details of the submitter and, where applicable , contact point  
– Name  
– Full address  
– Telephone number  
– E-mail address  
Contact details for rapid access to additional product information (24 hours/7 days). 
Only for limited submission.  
– Name  
– Telephone number ( accessible 24 hours per day, 7 days per week)  
– E-mail address’  
(b) in Section 1.3, the list of “Additional information on the mixture” is replaced by the 
following :  
‘ Additional information on the mixture  
– Colour(s)  
– The pH , if available, of the mixture as supplied, or , where the mixture  is a 
solid, the pH of an aqueous liquid or solution at a given concentration. The 
concentration of the test mixture in water shall be indicated . If the pH is not 
available, the reasons  shall be given ; 
– Physical  state(s)  
– Packaging (type(s) and size(s))  
– Intended use (product category ) 
– Uses (consumer, professional, industrial)’ .