Professional Documents
Culture Documents
The validity of this confirmation expires 12 months after receipt, after receiving a revised version
or in case of regulatory changes.
It is the responsibility of the downstream user or the manufacturer of the final food contact
material or article to determine that all conditions and specifications outlined in the following
regulations are met, and that the finished food contact materials and/or articles fabricated with our
above referenced product are safe and suitably pure for use in their intended food contact
applications.
Brazil
Maximum Limitations/
Polymer Type Reference
Concentration Restrictions
RESOLUÇÃO DA DIRETORIA COLEGIADA -
All Polymers RDC Nº 326, DE 3 DE DEZEMBRO DE 2019
No Estabelece a lista positiva de aditivos destinados à
in compliance with
limitations elaboração de materiais plásticos e revestimentos
RDC Nº 326, DE 3 Not applicable
or poliméricos em contato com alimentos e dá outras
DE DEZEMBRO
restrictions. providências.
DE 2019
(RDC Resolution Nº 326/2019)
China
Maximum
Polymer Type Limitations/Restrictions Reference
Concentration
No limitations and All Substances which are components of
restrictions. our above referenced product are listed
Complies with all in Appendix A
specifications and “Plastic Resins allowed for use and Use
requirements laid down Requirements” of
Food Packaging in GB 4806.6-2016. GB 4806.6-2016 “National Food
Materials It is the responsibility of Safety Standard Plastic Resin for
Not specified.
(Basic Food Contact the manufacturers of the Food Contact”.
Resins) final food contact AND
products to comply with Announcement No 11 of China's
all requirements and National Health Commission (NHC)
specifications existing for issued 2017.
his final polymeric food
contact material.
All components of our above referenced
product are listed in Appendix A, Table
A1 “food contact plastic materials and
Dosage as No limitations and their products - allowable additives with
Polyethylene (PE)
necessary. restrictions. their use requirements” of “National
Standard of Food Safety: on uses of
additives in Food Contact Materials and
their products” (GB 9685-2016).
European Union
“Framework” Regulation (EC) No 1935/2004 (as amended) of the European Parliament and of the Council
of 27 October 2004 on materials and articles intended to come into contact with food:
Please note that this regulation is not applicable to the abovementioned product as this product is not a finished
product in the sense of this regulation. Nevertheless this product meets the requirements of Article 3 of Regulation
(EC) No.1935/2004 of October 27th 2004 in so far as:
• this product is deemed not to endanger human health as required in Article 3 of Regulation (EC)
No.1935/2004 (please respect the limitations/specifications/requirements set out for this product in
Regulation (EU) No 10/2011)
• this grade is produced to comply with pre-established specifications and purity limits in accordance with
Article 8 of Regulation (EU) No 10/2011 (“General requirement on substances”)
• the production of the abovementioned grade is carried out in production units with the necessary quality
control systems, which enables traceability through all stages of productions.
Commission Regulation (EC) No 2023/2006 (as amended) of 22 December 2006 on good manufacturing
practice for materials and articles intended to come into contact with food (GMP):
As already set out above, we have installed a process allowing us to ensure traceability of the raw materials used in
the production of a specific batch of the product back to the suppliers. However, Article 2 of this regulation
excludes the production of starting substances from its scope of application.
• Additives and waxes (like our abovementioned products) are starting substances. Therefore the
manufacture of additives and waxes is exempted from this regulation.
1. This declaration was issued by: Clariant Produkte (Deutschland) GmbH, Ludwig-Hermann-Str. 100, D-
86368 Gersthofen, Germany
2. This product was manufactured by: Clariant Plastics & Coatings (Deutschland) GmbH
Trade name: Licowax® PE 520 (all physical forms)
FCM Substance Number 125, 275 (monomers)
Reference Number 16950, 23980 (monomers)
CAS Registry Number Not necessary. If available and applicable, please see our current safety
3. data sheets (SDS).
Dual-Use Information This product does not contain dual-use additives (i.e. additives which are
also authorized as food additives by Regulation (EC) No 1333/2008 or as
flavourings by Regulation (EC) No 1334/2008) in the sense of article 11 of
Regulation (EU) No 10/2011.
4.a. Date of Declaration: Date of reception (via email, e.g.)
4.b. This Declaration is valid until: 12 months after receipt or in case of regulatory changes.
5.a. Confirmation: All substances which are components of abovementioned product are
authorized to be used as additives in plastics complying with Regulation
(EU) No 10/2011.
5.b. Quality and purity confirmation: All substances which are components of our abovementioned product are
of a technical quality and purity suitable for the intended and foreseeable
use.
Information on Table 1 of Annex II: Our above referenced product is
not expected to contain substances listed in Table 1 of Annex II in any
reportable quantities.
Article 19: This product does not contain substances not listed in Annex I
of Regulation (EU) No 10/2011.
6.a. Relevant restrictions: No.
6.b. Compositional or purity No.
specifications as mentioned in
column 10 of Annex 1
6.c. Fat Consumption Reduction Factor Not applicable.
(FRF) applicable?
7. In case of Dual-Use additives: Not applicable (see 3).
Does the substance respect the
purity criteria for food additives?
8. Specifications of use (in relation to Not applicable.
the final article as indicated in
column 10 of Annex 1)
European Union
Resolution ResAP (2002) 1
The monomers used for the manufacture of our above referenced polymeric additive are included in "Appendix A (monomers
assessed)": of “TECHNICAL DOCUMENT No. 1” of “LIST OF SUBSTANCES TO BE USED IN THE MANUFACTURE OF
PAPER AND BOARD MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS".
SCF-Status
RESTRICTIONS
(for Plastics) ADI/TDI mg/kg
CAS RN Name AND/OR
or body weight
SPECIFICATIONS
SCF-List
74-85-1 Ethylene 3 - -
115-07-1 Propylene 3 - -
74-85-1 Ethylene 3 - -
115-07-1 Propylene 3 - -
74-85-1 Ethylene 3 - -
115-07-1 Propylene 3 - -
Germany (BfR-Recommendations)
Please note that only those BfR-recommendations are listed which cover applications other than
already covered by Regulation (EU) No 10/2011 (plastic applications). For this kind of applications
please see there.
Maximum
Polymer Type Limitations/Restrictions Reference
Concentration
Approved as an additive (in BfR recommendation XLIV
quantities less than 50%) in Hard
Paraffins, Microcrystalline Waxes
and Mixtures of these with Waxes,
Resins and Plastics (in accordance
with BfR-Recommendation XXV,
Artificial part I). These Hard Paraffins,
50%
Sausage Casings Microcrystalline Waxes and
Mixtures of these with Waxes,
Resins and Plastics are approved as
substances for the surface finishing
of artificial sausage casings
(synthetic sausage skins) made from
cellophane
Approved as an additive (in BfR recommendation XXI
quantities less than 50%) in Hard
Paraffins and Microcrystalline
Waxes in compliance with BfR-
Recommendation XXV. Mixtures of
Commodities on
Please see these Hard Paraffins and
the Basis of
“Limitations / Microcrystalline Waxes are
Rubber and
Restrictions”. approved for the use in the
Elastomers
manufacturing of rubber
commodities (in accordance with
BfR-Recommendation XXI) in
quantities up to 3% of the finished
article.
Approved as an additive for fillers BfR recommendation LII
(in quantities up to 12%) intended to
be used in all commodities/end
Fillers 12% articles which are not made from
plastics in compliance with the
plastics definition specified in the
German Commodities Ordinance.
Japan
Maximum
Limitations/
Polymer Type1 Concentration Reference
Restrictions
[weight %]
Japanese Ministry of Health,
Engineering Plastics Group
Polymers listed in "Group 1" of "List of 50 No Labour and Welfare
Base Polymers" Group 1
MERCOSUR
Maximum Limitations /
Polymer Type Reference
Concentration Restrictions
Section 4.3(e) of GMC Resolution No. 39/19
Plastic Materials and MERCOSUR "Technical Regulation on the
Polymeric Coatings that Positive List of Additives for the Preparation
Come into Contact with No limitations of Plastic Materials and Polymeric Coatings
Food Not applicable. and that Come into Contact with Food".
in compliance with Section restrictions.
4.3(e) of GMC Resolution
No. 39/19 MERCOSUR
Switzerland
Declaration of Compliance (DoC)
for substances authorized and listed in
Annex 10:
“List of authorized substances for the production of printing inks and the requirements
for these substances (“List of Substances”)
of
The Swiss ordinance of the FDHA on materials and articles intended to come into contact
with food (817.023.21)
All components of our above referenced product and/or all monomers used in the manufacturing process of our
above referenced product are listed in the “List of Substances”. For more details, please see below.
1 Substance number 602, 50
2 Chemical characterization Propylene, Ethylene
3 CAS registry number 115-07-1, 74-85-1
4 EU reference number 23980, 16950
5 Listed for the use as Monomers. Polymer is also listed.
6 Classification of the substance Monomers Part A, Polymer Part B
7 SML (specific migration limit) [mg/kg] None
8 SML [T] (group restriction) None
9 Restriction and specifications None
USA
Maximum
Polymer Type Limitations/Restrictions Reference
Concentration
Our above referenced product is clarified to
be safely used as a component of all
nonfood articles in contact with food
All plastics (including all food contact articles made
(clarification of the use of our Not specified. from plastics complying with applicable
above referenced product as a For further parts of 21 CFR (USA, FDA) or applicable
component of all food contact information, please Food Contact Notifications (FCN), subject 21 CFR
articles made from plastics see column to any applicable specifications and §178.3720
complying with applicable parts of "Limitations / extractives limitations stated in the
21 CFR or applicable Food Contact Restrictions" applicable regulations and notifications).
Notifications (FCN). Of course, the general provisions
applicable to all indirect food additives as
laid down in 21 CFR §174.5(2) have to be
respected (please see there).
Disclaimer
This information corresponds to the present state of our knowledge and is intended as a general description of our products
and their possible applications. Clariant makes no warranties, express or implied, as to the information’s accuracy, adequacy,
sufficiency or freedom from defect and assumes no liability in connection with any use of this information. Any user of this
product is responsible for determining the suitability of Clariant's products for its particular application. ٭Nothing included in
this information waives any of Clariant’s General Terms and Conditions of Sale, which control unless it agrees otherwise in
writing. Any existing intellectual/industrial property rights must be observed. Due to possible changes in our products and
applicable national and international regulations and laws, the status of our products could change. Material Safety Data
Sheets providing safety precautions, that should be observed when handling or storing Clariant products, are available upon
request and are provided in compliance with applicable law. You should obtain and review the applicable Material Safety
Data Sheet information before handling any of these products. For additional information, please contact Clariant.
٭For sales to customers located within the United States and Canada the following applies in addition: NO EXPRESS OR
IMPLIED WARRANTY IS MADE OF THE MERCHANTABILITY, SUITABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR OTHERWISE OF ANY PRODUCT OR SERVICE.
9/2010