legislation-obligation

Substance Regulatory Obligations

OBL

Zinc oxide

EC number: 215-222-5

CAS number: 1314-13-2

Last updated: 23/02/2021
ECHA Legislation Regulatory Obligations

Regulatory obligations may exist for this substance under the legislations under ECHA’s remit or for which ECHA has delegated tasks (i.e. REACH, CLP, BPR, PIC, CAD / CMD, WFD, and POPs). Please check the substance Infocard.

CAD - Chemical Agents Directive

CAD - Chemical Agents Directive, Article 2(b)(i) - Hazardous Agents

This list contains a non-exhaustive inventory based on the list of substances with harmonised classification and labelling (i.e., Table 3 of Annex VI to the CLP Regulation 1272/2008/EC). While the harmonised list covers many hazardous substances, others not listed may also meet the classification criteria in accordance with the CLP Regulation.

Name CAS
zinc oxide
1314-13-2
Construction Products Regulation

Construction Product Regulation - Annex I (3) - Hazardous Substances

This list contains a non-exhaustive inventory of substances taken from: (1) Table 3 of Annex VI to CLP; (2) the Candidate List of SVHCs; (3) Annex XIV of REACH (Authorisation List); (4) Annex XVII of REACH (Restrictions List); (5) F-gases subject to emission limits/reporting per Regulation 517/2014/EU; and (6) volatile organic compounds (VOCs) listed in the Ambient Air Directive 2008/50/EC. The basis of the list is Annex I(3) of the Construction Products Regulation 305/2011/EC, which stipulates that construction works must not have a high impact on human health or the environment as a result of: giving off toxic gas; emissions of dangerous substances, volatile organic compounds (VOC), greenhouse gases or dangerous particles into indoor or outdoor air; release of dangerous substances into drinking water, ground water, marine waters, surface waters or soil.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU FGG (517/2014) EU VOC (2008/50)
zinc oxide
1314-13-2
yes

Construction Product Regulation - Article 6(5) - SDS and Declaration

This list contains a non-exhaustive inventory of substances originating from: (1) Table 3 of Annex VI to CLP (i.e., the list of harmonised substances); (2) the Candidate List of Substances of Very High Concern (SVHCs); and REACH Annex XIV (Authorisation List). This list is compiled on the basis of Article 6(5) of Regulation 305/2011/EC on Marketing of Construction Products. This provision requires SDSs and information on hazardous substances (i.e., SVHCs) contained in construction products be provided with the declaration of performance.

Name CAS EU REACH: Annex XIV EU REACH: List of SVHC
zinc oxide
1314-13-2
Cosmetic Products Regulation

Cosmetic Products Regulation, Annex IV - Allowed Colorants

This list contains coloring agents allowed for use in cosmetic products marketed in the European Union. The list indicates the approved fields for application, including whether or not the colorant is permitted for use in products applied near the eye or on mucous membranes, or in products intended to come in contact with the skin.

Ref No. Substance Identification Conditions Notes  
Name EC Number CAS Colour index (CI) Number Colour Physical form Product type, body parts Restriction(s) Maximum Threshold Expressed As Function(s)
144
Zinc oxide
215-222-5
1314-13-2
77947
White
All cosmetic products
Not to be used in applications that may lead to exposure of the enduser's lungs by inhalation
Colorant
For use as a UV-filter, see Annex VI, No 30 and No 30a
Details

Cosmetic Products Regulation, Annex VI - Allowed UV Filters

This list contains substances designated as UV filters which cosmetic products marketed in the European Union may contain. The list contains concentration limits and additional restrictions, as well as labelling requirements for some substances.

Ref No. Substance Identification Conditions Warning Label Notes  
Name EC Number CAS Common Ingredients Physical form Product type, body parts Function(s) Maximum Threshold Restriction(s) Expressed As
30
Zinc oxide
215-222-5
1314-13-2
All cosmetic products
UV Filter
25 %
Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation
In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g
Details
30a
Zinc oxide
215-222-5
1314-13-2
Nano
All cosmetic products
UV Filter
25 %
Not to be used in applications that may lead to exposure of the end-user's lungs by inhalation
Only nanomaterials having the following characteristics are allowed: - Purity ≥ 96 %, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or isometric shapes, with impurities consisting only of carbon dioxide and water, whilst any other impurities are less than 1 % in total - Median diameter of the particle number size distribution D50 (50 % of the number below this diameter) > 30 nm and D1 (1 % below this size) > 20 nm - Water solubility < 50 mg/L - Uncoated, or coated with triethoxycaprylylsilane, dimethicone, dimethoxydiphenylsilanetriethoxycaprylylsilane cross-polymer, or octyl triethoxy silane
In case of combined use of zinc oxide and zinc oxide (nano), the sum shall not exceed the limit given in column g
Details
End-of-Life Vehicles Directive

End-of-Life Vehicles Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances as defined by Article 2(11) of the End-of-Life Vehicles Directive 2000/53/EC. It is based on the relevant subset of substances with harmonised classification listed in Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name CAS EU CLP (1272/2008)
zinc oxide
1314-13-2
Aquatic Acute 1; Aquatic Chronic 1
EU Ecolabel Regulation

Ecolabels - Restrictions for Hazardous Substances/Mixtures

This list contains: (1) the hazardous substances with harmonised classifications and labelling (i.e., Table 3 of Annex VI to CLP Regulation); and (2) the Candidate List of substances of very high concern (SVHC). The EU Ecolabel may not be awarded to substances or mixtures classified as such. Note that this list is not exhaustive. While the harmonised list covers many hazardous substances, others not listed may also meet classification criteria in accordance with the CLP Regulation.

Name CAS Restriction(s) Expressed As Table 3 of Annex VI to CLP EU REACH: List of SVHC Physical form Substance Description  
zinc oxide
1314-13-2
yes
Details
Food Contact Recycled Plastic Materials and Articles Regulation

FCMs Recycled Plastic & Articles Regulation - Annex I - Authorised Use

This list contains the Annex I Plastic Food Contact Materials (FCMs) authorised for use in the European Union under Regulation 10/2011/EU. Pursuant to Art. 4(b) of Directive 282/2008/EC on recycled plastic FCMs, plastic recycling processes can only be authorised if input originates from plastic materials and articles manufactured in accordance with EU legislation on plastic food contact materials and articles.

Name CAS Physical form FCM No Ref No. Additive or PPA Use as monomer/macromolecule FRF applicable SML (mg/kg) SML(T) Group Restriction No SML(T) Group FCM substances SML(T) (mg/kg) Restriction(s) Notes on verification Notes  
zinc oxide
1314-13-2
402
96240
yes
no
no
Details
zinc oxide
1314-13-2
nanoparticles, uncoated
1050
yes
no
no
Only to be used in unplasticised polymers.
Details
zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)
nanoparticles
1046
yes
no
no
Only to be used in unplasticised polymers.^The restrictions and specifications specified for FCM substance No 788 shall be respected.
Details
General Product Safety Directive

General Product Safety Directive - Hazardous Substances

This list contains a non-exhaustive inventory of substances that fall within the European Union's hazardous substance definitions, as provided on: (1) Table 3 of Annex VI to the CLP Regulation 1272/2008/EC; (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annexes XIV and XVII (Authorisation and Restriction lists). They can be considered hazardous for purposes of the General Product Safety Directive 2001/95/EC.

Name CAS EU CLP (1272/2008) EU REACH: Annex XIV EU REACH: List of SVHC EU REACH: Annex XVII EU_BA Directive 2000/54/EC
zinc oxide
1314-13-2
yes
Marine Environmental Policy Framework Directive

Marine Environmental Policy Framework Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances for purposes of the Marine Strategy Framework Directive, especially as it concerns Art. 3(8), and Annexes I and III. The listed substances meet the European Union's definitions as hazardous, as provided on: (1) Table 3 of Annex VI to the CLP Regulation (1272/2008/EC); (2) Annex III of Directive 2000/54/EC (Biological Agents); Candidate List of SVHCs; and REACH Annex XIV (Authorisation List).

Name CAS EU CLP (1272/2008) EU REACH: List of SVHC EU_BA Directive 2000/54/EC EU REACH: Annex XIV
zinc oxide
1314-13-2
yes
Plastic Materials and Articles Regulation

FCM and Articles Regulation, Annex I - Authorised Substances

This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. It is taken from Annex I of the Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.

Name CAS FCM No Ref No. Additive or PPA Use as monomer/macromolecule FRF applicable SML (mg/kg) SML(T) Group Restriction No SML(T) Group FCM substances SML(T) (mg/kg) Restriction(s) Notes on verification Notes Physical form Group name Expressed As  
zinc oxide
1314-13-2
402
96240
yes
no
no
Details
zinc oxide
1314-13-2
1050
yes
no
no
Only to be used in unplasticised polymers.
nanoparticles, uncoated
Details
zinc oxide, coated with [3-(methacryloxy)propyl] trimethoxysilane (FCM No 788)
1046
yes
no
no
Only to be used in unplasticised polymers.
The restrictions and specifications specified for FCM substance No 788 shall be respected.
nanoparticles
Details
WFD - Waste Framework Directive

Waste Framework Directive, Annex III - Waste - Hazardous Properties

This list contains substances that have been assigned hazard property (HP) waste codes 1-15, as defined in terms of the hazard class and category, hazard (H) statement, and/or concentration limits provided in Annex III of the Waste Framework Directive 2008/98/EC. The classifications of the substances listed in the list are based on their harmonised classifications per Table 3 of Annex VI to the CLP Regulation 1272/2008/EC.

Name EC Number CAS EU CLP (1272/2008) HP Code Index
zinc oxide
215-222-5
1314-13-2
Aquatic Acute 1
Aquatic Chronic 1
HP14 Ecotoxic: waste which presents or may present immediate or delayed risks for one or more sectors of the environment.
030-013-00-7

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