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Product Safety Declaration - Finolene Blue GSP-3610 - Version 1.0 - 21 Agst 2023
Product Safety Declaration - Finolene Blue GSP-3610 - Version 1.0 - 21 Agst 2023
Product Safety Declaration - Finolene Blue GSP-3610 - Version 1.0 - 21 Agst 2023
Introduction
All statements refer exclusively to the named product in its current formulation: they are based on the present
state of our knowledge and experience and concern the product in its original form and packaging as supplied
from our factory.
Since the masterbatch or compound manufacturer has no influence on subsequent processing, the processor
himself is responsible for ensuring that the finished article is suitable for the intended use and is also
responsible for ascertaining the compliance of the end article with the national and international regulations
and laws concerning its application field.
Indonesia National Agency of Drug and Food Control (BPOM) Regulation No. 20
Year 2019 (former Regulation No. HK 00.05.55.6497) on food packaging
materials
Food, including food packaging, is regulated under Law 18/2012 in Indonesia. Known as the new Food Law, it
replaced the Food Act of 1996 (Law 7/1996). Law 18/2012 requires that the food supply be sufficient, safe,
high quality, diverse, affordable, and not conflict with religion, beliefs, and culture. In this regard, it imposes a
broad range of pre-market and post-market controls to try to ensure food safety.
Indonesia's new Food Law defines "Food Packaging" as "material used to enclose and/or wrap Food that is in
contact both directly as well as indirectly." The use of food packaging that is hazardous to human health or
releases pollutants that are hazardous to human health is banned in Part Six, which specifically addresses food
packaging.
The National Agency of Drug and Food Control (BPOM) Regulation No. 20 Year 2019 on food packaging
materials includes lists of prohibited (Annex 1), permitted with migration limitation (Annex 2A) and permitted
without migration limitation (Annex 2B), food packaging materials (substances) in plastics, printing ink,
rubber, elastomer, caps, gaskets, seals, paper, plastics, ceramics, glass and metals.
Based on the knowledge of all raw materials as well as of the manufacturing process, we are able to confirm
that the product does not contain intentionally added materials listed in Annex 1 of The National Agency of
Drug and Food Control (BPOM) Regulation No. 20 Year 2019 on food packaging materials.
All information given herein are based on our good faith and corresponds to the present state of our knowledge
and is intended as a general description of our products and their possible applications. As regulations on food-
contact packaging are different in many countries, and conditions of use of our product beyond our control,
therefore, it is a responsibility of finished articles producers to ensure compatibility of their products with those
regulations in concern.
Product Safety Declaration
Revision date : 21-Ags-2023
Page 2 of 5 Printed date : 21-Ags-2023
In term of end articles, this regulation is not applicable to us as we do not produce end articles, therefore, it is
the manufacturer of the end article intended to come into contact with food obliged to fulfill the requirements
of the Regulation No 1935/2004. It is therefore your responsibility to comply with the regulation. However, in
order that you are in a position to ensure the traceability as required by the regulation, as a producer of one of
the material, we are please to provide you with information of merely our product in relation to this regulation.
Plastic materials are covered by specific measures in relation with component type used in the formulation of
the mixtures:
• polymers and additives are regulated by Regulation (EU) No. 10/2011;
• colorants (including dyes, organic and inorganic pigments), providing that they don’t migrate even in traces,
follow purity requirements laid down in the national laws of Member States where end article is put on the
market and the not legal binding requirements of AP(89) 1 of Council of Europe;
• catalysts, solvent and polymer production aids (not yet listed at EU level) shall be assessed with general
rules of Framework Regulation by substance manufacturer and/or shall comply with the national legislations
provisions.
Regulation (EU) No. 10/2011 on plastic materials and articles intended to come
into contact with food (former Directive 2002/72/EC)
Generally the compositions of our products are company know how. However, we would like to inform as
follows:
The product contains one or more additive(s) which is (are) listed on the Regulation (EU) No. 10/2011 (no SML).
We remind you that the assessment of overall migration limits (and any other specific migration limit) and of
the release of aromatic amines according Annex V part A of 2007/19/EC are in the area of responsibility of the
end article producer.
All colorants used in the above mentioned product meets the purity requirements of the Resolution AP (89) 1,
as follows :
All information given herein are based on our good faith and corresponds to the present state of our knowledge
and is intended as a general description of our products and their possible applications. As regulations on food-
contact packaging are different in many countries, and conditions of use of our product beyond our control,
therefore, it is a responsibility of finished articles producers to ensure compatibility of their products with those
regulations in concern.
Product Safety Declaration
Revision date : 21-Ags-2023
Page 3 of 5 Printed date : 21-Ags-2023
All the colorants used do not show any objections to their use according to the recommendations of the BfR
(Bundesinstitut für Risikobewertung; Federal Institute for Risk Assessment) contained into Empfehlungen IX
and meet its purity requirements as follows :
Based on the knowledge of the raw materials as well as of the manufacturing process, we are able to confirm
that the product does not contain intentionally added heavy metals. The above-mentioned product fulfils the
requirements of EU-Directive 94/62/EC and the CONEG legislation; that is, the cumulative content of Cd, Pb, Hg
and Cr(VI) is less than 100ppm.
We herewith confirm that substances restricted by directive 2011/65/EU (Heavy metals (Cd, Pb, CrVI, Hg), PBB,
PBDE) are not intentionally added to the product.
All information given herein are based on our good faith and corresponds to the present state of our knowledge
and is intended as a general description of our products and their possible applications. As regulations on food-
contact packaging are different in many countries, and conditions of use of our product beyond our control,
therefore, it is a responsibility of finished articles producers to ensure compatibility of their products with those
regulations in concern.
Product Safety Declaration
Revision date : 21-Ags-2023
Page 4 of 5 Printed date : 21-Ags-2023
Remark :
Polybrominated biphenyls (PBB) and polybrominated diphenylethers (PBDE) are neither used for the
manufacturing of the product nor added to the end product.
EN 71/ Part 3
The above-mentioned product does not exceed the heavy metal limits laid down in the European Standard EN
71, part 3 "Safety of toys".
Hazardous Substances Max Conc. In 0.07 N HCl
Arsenic (As) < 25 ppm
Barium (Ba) < 1000 ppm
Cadmium (Cd) < 75 ppm
Chromium (Cr) < 60 ppm
Mercury (Hg) < 60 ppm
Lead (Pb) < 90 ppm
Antimony (Sb) < 60 ppm
Selenium (Se) < 500 ppm
Cadmium compound
The components of the above mentioned product do not contain intentionally added cadmium compounds in
their chemical constitution.
Diarylide Pigments
The components of the above-mentioned product do not contain diarylide pigments in their chemical
constitution. These pigments must not be used in polymers if the processing temperature exceeds 200°C
because of possible thermal decomposition which can form e.g. traces of aromatic amines. (See MSDS, further
information also in ETAD Information Notice No.2 "Thermal Decomposition of Diarylide Pigments" - September
1990.
Lead compounds
In accordance with its constitution the above mentioned product do not contain lead compounds.
Chromium VI
Chromium VI is not used for the manufacturing of the above mentioned product nor added to the final
product.
Phthalates
Phtalates are not used for the manufacturing of the above mentioned product nor added to the final product.
Nonylphenol
Nonylphenol is not used for the manufacturing of the above mentioned product nor added to the final product.
Nonylphenol ethoxylates
Nonylphenol ethoxylates are not used for the manufacturing of the above mentioned product nor added to the
final product.
All information given herein are based on our good faith and corresponds to the present state of our knowledge
and is intended as a general description of our products and their possible applications. As regulations on food-
contact packaging are different in many countries, and conditions of use of our product beyond our control,
therefore, it is a responsibility of finished articles producers to ensure compatibility of their products with those
regulations in concern.
Product Safety Declaration
Revision date : 21-Ags-2023
Page 5 of 5 Printed date : 21-Ags-2023
Alkylphenols
Alkylphenols are not used for the manufacturing of the above mentioned product nor added to the final
product.
Alkylphenol ethoxylates
Alkylphenolethoxylate (APEO) is not used for the manufacturing of the above mentioned product nor added to
the final product.
Formaldehyde
Formaldehyd is not used for the manufacturing of the above mentioned product nor added to the final
product.
Tributyltin-Compounds
Tributyltin-compounds are not used for the manufacturing of the above mentioned product nor added to the
final product.
Melamine
Melamine is not used for the manufacturing of the above mentioned product nor added to the final product.
Tangerang, 21-Ags-2023
All information given herein are based on our good faith and corresponds to the present state of our knowledge
and is intended as a general description of our products and their possible applications. As regulations on food-
contact packaging are different in many countries, and conditions of use of our product beyond our control,
therefore, it is a responsibility of finished articles producers to ensure compatibility of their products with those
regulations in concern.