Colorants portfolio for sensitive applications - BASF

1 Colorants portfolio for sensitive applicationsPigments for plastics3 Pigments for plasticsTable of contentsTable of contentsIntroduction 4 Colorants for toys 28 Legislation for food contact materials 39 Colorants for food contact materials 8 Colorants portfolio for sensitive applications 6 Legislation on toys 45 Appendix: Defi nitions and abbreviations 48 Disclaimer 47 Other sensitive applications 465 Pigments for plasticsIntroductionThis document gives an overview of basf selected Colorants portfolio for plastics listed by national regulations and additionally provides a summary of the key regulations ruling Colorants for plastics going into food contact materials and toys. It is meant as a general introduction for everyone who wants to get a baseline understanding of the regulatory framework for food contact material and toys.

2 If further information is required, please contact general comments are provided, the original text of the law or standard has to be consulted to avoid misunderstandings and incorrect information in this document has been compiled with great care and reflects basf best knowledge at the date of issue (September 2017). Due to continuous evolution of the subject, information may rapidly change and therefore this document can only be considered as a snapshot of the current situation as at the date of publication (September 2017). To ensure the full updated compliance status of a given product to the newest legislation requirements or technology changes, we strongly recommend that our customers systematically check this status with their basf representative or contact basf via for plastics67 Pigments for plasticsColorants portfolio for sensitive applicationsColorants portfolio for sensitive applicationsDefinition and revisions basf Colorants for plastics portfolio screened for sensitive applications have been initially assessed through specific criteria such as product fingerprint including purity profile, as well as manufacturing set-up including consideration of cross-contamination , when necessary, product processing behavior in plastics was assessed and when needed, a product would have to undergo a risk assessment under standard or specific conditions of those products.

3 The Management of Change process at basf systematically aims at retaining existing compliance status for products affected by modifications such as raw materials changes or manufacturing process scopingThis document lists the basf portfolio of Colorants for plastics and fibers that will be actively supported for use in sensitive applications such as food packaging and compliance status of basf organic, inorganic and effect pigments as well as polymer soluble Colorants and pigments preparations is provided in the Appendix table, listed for each product per national a result of all those precautionary measures, basf can now, for all products listed in this Colorants port-folio for sensitive applications , deliver Food Contact Certificates (FCC) moving forward. FCC provided by basf for plastic food contact materials is the official document that covers the EU declaration of Compliance (DoC) legal requirements as well as the compliance requirements of other regional jurisdictions as Colorants portfolio for sensitive applications is regularly reviewed in line with evolving regulatory requi-rements, new developments in product technol ogy and new findings in legal environment or product order to ensure that the regulatory requirements are continuously met, the basf Food Contact Certificates for products in our Colorants portfolio for food contact applications in plastics are updated on a 18 months basis, in order to cover the periodic updates of the Plastics Regulation (EU) No.

4 10/2011, or earlier in case of relevant regulatory basf Food Contact Certificates for Colorants portfolio for food contact applications in Plastics are valid for 18 though it is the intention of basf to sustain as much as possible the compliance scope and depth of the selective Colorants portfolio for sensitive applications , no guarantee can be given that all products will remain compliant under all circumstances, , future evolu-tions of the regulatory environment. In such cases that shall remain exceptional, basf will strive to provide updated information to customers with pre-notice portfolio for sensitive applicationsPurity limits for basf products in color-ants portfolio for sensitive applications For products that have been selected in basf Colorants portfolio for sensitive applications , spot testing program with an adapted testing scope and frequencies are defined in order to regularly check that products are manufactured in line with target purity levels.

5 If required, spot testing can be extended for systematic batch to batch analysis by setting up an internal specification ensuring strict monitoring of target purity profile. Typical purity limits as defined by basf for Colorants portfolio for sensitive applications are detailed below ( basf Purity Limits):Table 1: basf purity limitsExtractable impurity in the colorantLimit [ppm]Aluminum (Al)1,000 Antimony (Sb)45 Arsenic (As)3 Barium (Ba)100 Boron (B)1,000 Cadmium (Cd)1 Chromium (Cr III + Cr VI)1 Cobalt (Co)10 Copper (Cu)600 Lead (Pb)2 Manganese (Mn)800 Mercury (Hg)5 Nickel (Ni)50 Selenium (Se)25 Strontium (Sr)4,500 Tin (Sn)15,000 Zinc (Zn)1,000 Iron (Fe)4,500 Lithium (Li)500 Primary aromatic amines (PAA)500 Benzidine, beta-naphthylamine, 4-aminobiphenyl10 Polychlorinated biphenyls (PCB)25 These purity limits make it possible to meet the require-ments of most of the targeted end use applications , , food contact packaging and toys for plasticsColorants for food contact materials Status as of September 2017 This portfolio is regularly reviewed according to business needs and regulatory requirements.

6 For any updates please contact the overview of products compliance status in the tables on the next pages should be used as a general guide only. In any case, it does not replace the product detailed information in the Food Contact Certifi more detailed information on specifi c country requirements and conditions of use, please refer to the relevant Food Contact Certifi cates, which are available via upon for food contact materialsPigments for plastics1011 Pigments for plasticsColorants for food contact materials Colorants for food contact materials* For more information please contact September 2017 Colorants for food contact materials1 Compliant 5 Compliant with use restrictions* 0 Not compliantProductOld product nameFood Contact RegulationsEuropean UnionUSAJ apanAustraliaChinaMercosur1935/2004/EC - Art. 3EC Regulation 10/2011 AP(89)1 GermanyBfR IXFranceBrochure 1227 SpainReal Decreto 847/2011 ItalyDecreto 21/3/73 FDA.

7 21 CFR JHOSPAJHPAAS nN 15/2010 Cinquasia Magenta K 4535 Cinquasia Magenta RT-235-DPR 202111551155 1 1511 Cinquasia Magenta K 4535 FPCromophtal Magenta PPR 202111551155 1 1511 Cinquasia Pink K 4410 Cromophtal Pink 2000PR 12211151 1155 1 151-Cinquasia Pink K 4430 FPCromophtal Pink PTPR 12211151 1155 1 1511 Cinquasia Red K 4104 Cromophtal Red 2020PV 1911151 1155 1 1511 Cinquasia Red K 4111 Cromophtal Red TBRPV 1910150 0050 510--Cinquasia Red K 4330 Cinquasia Red B RT-195-D-11150 1155 0 1511 Cinquasia Violet K 5350 Cinquasia Violet R RT-891-DPV 1915150 5555 0 1511 Cinquasia Violet K 5350 FPCromophtal Violet RPPV 1915150 5555 0 1511 Cromophtal Brown K 3001 Cromophtal Brown 5 RPBr 2311151 110 5 5151-Cromophtal Orange K 2960 Cromophtal Orange GPPO 6411151 1155 0 1511 Cromophtal Red K 3830 Cromophtal Red GPR 220111551155 51511 Cromophtal Red K 3890 Cromophtal Red BRNPR 14411155110 5 51511 Cromophtal Red K 3890 FPCromophtal Red BRNPPR 14411155110 5 51511 Cromophtal Red K 3900 Cromophtal Red BNPR 21411155110 5 51511 Cromophtal Red K 3900 FPCromophtal Red BNFPPR 21411155110 5 51511 Cromophtal Red K 4035 Cromophtal Red 2 BPR 22111151 110 5 5151-Cromophtal Scarlet K 3540 Cromophtal Scarlet RNPR 16611155110 5 51511 Cromophtal Violet K 5700 Cromophtal Violet BPV 3711151 110 5 51511 Cromophtal Yellow 2GF-PY 155111551100 510--Cromophtal Yellow K 0990 Cromophtal Yellow 8 GNPY 12811151 110 5 5151-Cromophtal Yellow K 0990 FPCromophtal Yellow 8 GNPPY 12811151 110 5 5151-Cromophtal Yellow K 1210 Cromophtal Yellow 3 GPY 93111551155 51511 Cromophtal

8 Yellow K 1210 FPCromophtal Yellow 3 GNPPY 93111551155 51511 Cromophtal Yellow K 1310 Cromophtal Yellow 4 GVPY 21515150 5555 0 10--Cromophtal Yellow K 1410 Cromophtal Yellow 2 GOPY 18011151 1155 0 1511 Cromophtal Yellow K 1500 Cromophtal Yellow GRPY 9511151 1155 51511 Cromophtal Yellow K 1500 FPCromophtal Yellow GRPPY 9511151 1155 51511 Eupolen PE Blue 69-1501-PB 15:155150 5550 0 50-5 Eupolen PE Blue 69-2001-PB 15:115115 5550 1 1511 Eupolen PE Blue 69-2004-PB 15:115115 5550 1 1511 Pigments for plastics1213 Pigments for plasticsColorants for food contact materials Colorants for food contact materialsStatus: September 2017* For more information please contact Compliant 5 Compliant with use restrictions* 0 Not compliantProductOld product nameFood Contact RegulationsEuropean UnionUSAJ apanAustraliaChinaMercosur1935/2004/EC - Art.

9 3EC Regulation 10/2011 AP(89)1 GermanyBfR IXFranceBrochure 1227 SpainReal Decreto 847/2011 ItalyDecreto 21/3/73 FDA, 21 CFR JHOSPAJHPAAS nN 15/2010 Eupolen PE Blue 69-2005-PB 15:115115 5550 1 1511 Eupolen PE Blue 70-9001-PB 15:315115 5550 1 1511 Eupolen PE Blue 70-9004-PB 15:315115 5550 1 1511 Eupolen PE Blue 70-9005-PB 15:315115 5550 1 1511 Eupolen PE Blue 71-0401-PB 15:415110 5550 0 10-1 Eupolen PE Brown 29-1505-PR 10115115 5550 1 1511 Eupolen PE Green 87-3001-PG 755155 5550 5 5515 Eupolen PE Green 87-3004-PG 755155 5550 5 5515 Eupolen PE Green 87-3005-PG 755155 5550 5 5515 Eupolen PE Green 87-3501-PG 755155 5550 0 5515 Eupolen PE Green 93-6001-PG 3655155 5550 0 5515 Eupolen PE Red 39-1101-PR 17851151 1150 0 1511 Eupolen PE Red 47-9001-PR 12211151 1150 1 1511 Eupolen PE Yellow 09-6101-PY 13851155 5550 5 551-Eupolen PE Yellow 11-5501-PY 18551110 1100 0 10--Eupolen PE Yellow 13-1501-PY 21515150 5550 0 10--Eupolen PE Yellow 17-6001-PY 191:115155 5550 0 1511 Eupolen PE Yellow 17-6004-PY 191.

10 115155 5550 0 1511 Eupolen PE Yellow 18-0001 Eupolen PE Yellow 22-7001PY 18311151 1150 0 1511 Eupolen PE Yellow 18-4101-PY 13951110 1100 0 10-1 Eupolen PE Yellow 18-4104-PY 13951110 1100 0 10-1 Eupolen PE Yellow 18-4105-PY 13951110 1100 0 10-1 Eupolen PE Yellow 20-8501-PY 11015155 5550 0 1511 Firemist Blue 9G630L--11111 1150 1 151-Firemist Gold 9G230L--11111 1150 1 151-Firemist Green 9G830L--11111 1150 1 151-Firemist Pearl 9G130L--11111 1150 1 151-Firemist Red 9G430L--11111 1150 1 151-Firemist Turquoise 9G730L--11111 1150 1 151-Firemist Violet 9G530L--11111 1150 1 151-Glacier Crystal White EH 1030--11110 1150 0 10-- Colorants for food contact materialsPigments for plastics1415 Pigments for plasticsColorants for food contact materials Colorants for food contact materialsStatus: September 2017* For more information please contact Compliant 5 Compliant with use restrictions* 0 Not compliantProductOld product nameFood Contact RegulationsEuropean UnionUSAJ apanAustraliaChinaMercosur1935/2004/EC - Art.