legislation-obligation

Substance Regulatory Obligations

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Confidential or not yet assessed substance

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Last updated: 03/04/2024

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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.

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Active Implantable Medical Devices Directive-repealed

Active Implantable Medical Devices Directive - Hazardous Substances

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name	CAS	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
magnesium sodium fluoride silicate	37296-97-2	STOT RE 2

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Cosmetic Products Regulation

Cosmetic Products Regulation, Annex III - Restricted Substances

This list contains substances whose use in cosmetic products in the European Union is banned, except under certain conditions as indicated in Annex III. The list specifies the field of application or use, maximum allowable concentration limits in finished products, and any additional limitations.

Ref No.	Substance Identification			Restrictions							Warning Label	Notes
Ref No.	Name	EC Number	CAS	Product type, body parts	Function(s)	Maximum Threshold	Minimum Threshold	Restriction(s)	Qualifier(s)	Expressed As	Warning Label	Notes
326	C.I. Acid Yellow 3		8004-92-0	Non-oxidative hair dye products		0.5 %						From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market. For use as a colorant, see Annex IV, entry No 82.	Details

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Food Contact Recycled Plastic Materials and Articles Regulation-repealed

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
silicic acid, magnesium-sodium-fluoride salt	37296-97-2		685	85950	yes	no	no	0.15 mg/kg				SML expressed as fluoride.^Only to be used in layers of multi-layer materials not coming into direct contact with food.			Details

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In Vitro Diagnostic Medical Devices Directive-repealed

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Name	CAS	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
magnesium sodium fluoride silicate	37296-97-2	STOT RE 2

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Medical Devices Directive-repealed

Medical Devices Directive - Hazardous Substances

This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 93/42/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Name	CAS	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
magnesium sodium fluoride silicate	37296-97-2	STOT RE 2

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Pesticide Residues Regulation

Annexes II, III, IV, VII - Defined & Temporary Maximum Residue Levels

This list contains the maximum residue level (MRLs) entries as listed in the following annexes of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC: (1) Annex II: Maximum Residue Levels; (2) Annex III: Temporary MRLs; (3) Annex IV: Active Substances for Which No MRLs Are Required; and (4) Annex VII: Active Substance/Product Combinations.

Name	Annex No.	Product Name	Category CodeNumber	Category	Group/SubGroup CodeNumber	Group/SubGroup	MRL
Fatty alcohols	Annex IV	All Products						Details
2,4-DB conjugates	Annex II		0200000	Vegetables, fresh or frozen	0230000	Fruiting vegetables		Details
2,4-DB conjugates	Annex II		1000000	Products of animal origin - Terrestrial animals	1040000, 1050000, 1060000, 1070000	Honey and other apiculture products; Amphibians and Reptiles; Terrestrial invertebrate animals; Wild terrestrial vertebrate animals		Details
2,4-DB conjugates	Annex II	Lamb's lettuces/corn salads Lettuces Escaroles/broad-leaved endives Cresses and other sprouts and shoots Land cresses Roman rocket/rucola (Wall rocket) Red mustards Baby leaf crops (including brassica species) Other lettuces and salad plants	0200000	Vegetables, fresh or frozen	0250000	Leaf vegetables, herbs and edible flowers		Details
2,4-DB conjugates	Annex II	Cultivated fungi Wild fungi Mosses and lichens	0200000	Vegetables, fresh or frozen	0280000	Fungi, mosses and lichens		Details
2,4-DB conjugates	Annex II	Blueberries Cranberries Currants (black, red and white) Gooseberries (green, red and yellow) Rose hips Mulberries (black and white) Azaroles/Mediterranean medlars Elderberries Other small fruits and berries	0100000	Fruits, fresh or frozen and Tree nuts	0150000	Berries and small fruits		Details
2,4-DB conjugates	Annex II	Saffron Other flower pistil spices	0800000	Spices	0860000	Flower pistil spices		Details
2,4-DB conjugates	Annex II	Broccoli Cauliflowers Other flowering brassica	0200000	Vegetables, fresh or frozen	0240000	Brassica vegetables (excluding brassica roots and brassica baby leaf crops)		Details
2,4-DB conjugates	Annex II	Anise/aniseed Black caraway/black cumin (Nigella) Celery (Angelica, Lovage) Coriander Cumin Dill Fennel Fenugreek Nutmeg Other seed spices	0800000	Spices	0810000	Seed spices		Details
2,4-DB conjugates	Annex II	Garlic (Twistedleaf garlic) Onions Shallots Spring onions/green onions and Welsh onions Other bulb vegetables	0200000	Vegetables, fresh or frozen	0220000	Bulb vegetables		Details
2,4-DB conjugates	Annex II	Muscle Fat Liver Kidney Edible offals (other than liver and kidney) Other commodities from swine	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities		Details
2,4-DB conjugates	Annex II		0600000	Teas, Coffee, Herbal Infusions, Cocoa and Carobs	0630000	Herbal infusions from		Details
2,4-DB conjugates	Annex II	Beans (Species listed with code numbers 0260010-xxx, dried seeds, except soyabeans/edamame) Lentils Peas Lupins/lupini beans Other pulses	0300000	Pulses				Details
2,4-DB conjugates	Annex II	Cinnamon Other bark spices	0800000	Spices	0830000	Bark spices		Details
2,4-DB conjugates	Annex II	Avocados Bananas Mangoes Papayas Granate apples/pomegranates Cherimoyas Guavas Pineapples Breadfruits Durians Soursops/guanabanas Other inedible peel, large	0100000	Fruits, fresh or frozen and Tree nuts	0160000	Miscellaneous fruits		Details
2,4-DB conjugates	Annex II	Beans (with pods) Beans (without pods) Peas (with pods) Peas (without pods) Lentils Other legume vegetables	0200000	Vegetables, fresh or frozen	0260000	Legume vegetables		Details
2,4-DB conjugates	Annex II	Table grapes Wine grapes	0100000	Fruits, fresh or frozen and Tree nuts	0150000	Berries and small fruits		Details
2,4-DB conjugates	Annex II	Chamomile Hibiscus/roselle Rose Jasmine Lime/linden Other Herbal infusions from flowers	0600000	Teas, Coffee, Herbal Infusions, Cocoa and Carobs	0630000	Herbal infusions from		Details
2,4-DB conjugates	Annex II	Beetroots Carrots Celeriacs/turnip rooted celeries Horseradishes Jerusalem artichokes Parsnips Parsley roots/Hamburg roots parsley Radishes Salsifies Swedes/rutabagas Turnips ) Other root and tuber vegetables except sugar beets	0200000	Vegetables, fresh or frozen	0210000	Root and tuber vegetables		Details
2,4-DB conjugates	Annex II		0700000	Hops				Details
2,4-DB conjugates	Annex II	Valerian Ginseng (Siberian ginseng) Other Herbal infusions from roots	0600000	Teas, Coffee, Herbal Infusions, Cocoa and Carobs	0630000	Herbal infusions from		Details
2,4-DB conjugates	Annex II	Cucumbers Gherkins (Bur gherkins) Courgettes Other cucurbits with edible peel	0200000	Vegetables, fresh or frozen	0230000	Fruiting vegetables		Details
2,4-DB conjugates	Annex II	Brussels sprouts Head cabbages Other head brassica	0200000	Vegetables, fresh or frozen	0240000	Brassica vegetables (excluding brassica roots and brassica baby leaf crops)		Details
2,4-DB conjugates	Annex II	Apricots Cherries (sweet) Peaches Plums Other stone fruits	0100000	Fruits, fresh or frozen and Tree nuts	0140000	Stone fruits		Details
2,4-DB conjugates	Annex II		0100000	Fruits, fresh or frozen and Tree nuts	0150000	Berries and small fruits		Details
2,4-DB conjugates	Annex II	Apples Pears Quinces Medlars Loquats/Japanese medlars Other pome fruits	0100000	Fruits, fresh or frozen and Tree nuts	0130000	Pome fruits		Details
2,4-DB conjugates	Annex II	Buckwheat and other pseudocereals Maize/corn Common millet/proso millet Rice Sorghum Other cereals	0500000	Cereals				Details
2,4-DB conjugates	Annex II	Chinese cabbages/pe-tsai Kales Other leafy brassica	0200000	Vegetables, fresh or frozen	0240000	Brassica vegetables (excluding brassica roots and brassica baby leaf crops)		Details
2,4-DB conjugates	Annex II		0200000	Vegetables, fresh or frozen	0210000	Root and tuber vegetables		Details
2,4-DB conjugates	Annex II	Strawberry Rooibos Mate/maté Other Herbal infusions from leaves and herbs	0600000	Teas, Coffee, Herbal Infusions, Cocoa and Carobs	0630000	Herbal infusions from		Details
2,4-DB conjugates	Annex II	Mace Other aril spices	0800000	Spices	0870000	Aril spices		Details
2,4-DB conjugates	Annex II	Tomatoes Sweet peppers/bell peppers Aubergines/eggplants Okra/lady's fingers Other solanaceae and malvaceae	0200000	Vegetables, fresh or frozen	0230000	Fruiting vegetables		Details
2,4-DB conjugates	Annex II		0200000	Vegetables, fresh or frozen	0240000	Brassica vegetables (excluding brassica roots and brassica baby leaf crops)		Details
2,4-DB conjugates	Annex II	Muscle Liver Kidney Edible offals (other than liver and kidney) Other commodities from poultry	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities		Details
2,4-DB conjugates	Annex II	Liquorice Ginger Turmeric/curcuma Horseradish Other root and rhizome spices	0800000	Spices	0840000	Root and rhizome spices		Details
2,4-DB conjugates	Annex II		0600000	Teas, Coffee, Herbal Infusions, Cocoa and Carobs	0610000, 0620000, 0640000, 0650000	Teas; Coffee beans; Cocoa beans; Carobs/Saint John's breads		Details
2,4-DB conjugates	Annex II	Dates Figs Table olives Kumquats Carambolas Kaki/Japanese persimmons Jambuls/jambolans Other edible peel	0100000	Fruits, fresh or frozen and Tree nuts	0160000	Miscellaneous fruits		Details
2,4-DB conjugates	Annex II	Asparagus (Hop sprouts) Cardoons (Borage stems) Celeries Florence fennels Globe artichokes Leeks Rhubarbs Bamboo shoots Palm hearts Other stem vegetables	0200000	Vegetables, fresh or frozen	0270000	Stem vegetables		Details
2,4-DB conjugates	Annex II	Blackberries Dewberries Raspberries (red and yellow) Other cane fruits	0100000	Fruits, fresh or frozen and Tree nuts	0150000	Berries and small fruits		Details
2,4-DB conjugates	Annex II	Cloves Capers Other bud spices	0800000	Spices	0850000	Bud spices		Details
2,4-DB conjugates	Annex II	Allspice/pimento Sichuan pepper Caraway (Ajowan) Cardamom (Marjoram, Star anise) Juniper berry Peppercorn Vanilla Tamarind Other fruit spices	0800000	Spices	0820000	Fruit spices		Details
2,4-DB conjugates	Annex II	Melons Pumpkins Watermelons Other cucurbits with inedible peel	0200000	Vegetables, fresh or frozen	0230000	Fruiting vegetables		Details
2,4-DB conjugates	Annex II	Kiwi fruits (green, red, yellow) Litchis/lychees Passionfruits/maracujas Prickly pears/cactus fruits Star apples/cainitos American persimmons/Virginia kaki Other inedible peel, small	0100000	Fruits, fresh or frozen and Tree nuts	0160000	Miscellaneous fruits		Details
2,4-DB conjugates	Annex II	Cassava roots/manioc Sweet potatoes Yams Arrowroots Other tropical root and tuber vegetables	0200000	Vegetables, fresh or frozen	0210000	Root and tuber vegetables		Details
2,4-DB conjugates	Annex II	Spinaches Purslanes Chards/beet leaves Other spinaches and similar leaves	0200000	Vegetables, fresh or frozen	0250000	Leaf vegetables, herbs and edible flowers		Details
2,4-DB conjugates	Annex II	Chervil Chives Celery leaves Parsley (Root parsley leaves) Sage Rosemary Thyme Basil and edible flowers Laurel/bay leaves Tarragon Other herbs and edible flowers	0200000	Vegetables, fresh or frozen	0250000	Leaf vegetables, herbs and edible flowers		Details
2,4-DB conjugates	Annex II	Sugar beet roots Sugar canes Chicory roots Other sugar plants	0900000	Sugar plants				Details
2,4-DB conjugates	Annex II		0200000	Vegetables, fresh or frozen	0250000	Leaf vegetables, herbs and edible flowers		Details
2,4-DB conjugates	Annex II	Kidney Edible offals (other than liver and kidney) Other commodities from sheep	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.1 mg/kg	Details
2,4-DB conjugates	Annex II	Liver	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.4 mg/kg	Details
2,4-DB conjugates	Annex II	Liver	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.4 mg/kg	Details
2,4-DB conjugates	Annex II	Kidney Edible offals (other than liver and kidney) Other commodities from other farmed terrestrial animals	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.1 mg/kg	Details
2,4-DB conjugates	Annex II	Cattle Sheep (Mouflon (farmed)) Goat Horse Other milk	1000000	Products of animal origin - Terrestrial animals	1020000, 1030000	Milk; Birds eggs	1.5 mg/kg	Details
2,4-DB conjugates	Annex II	Barley Oat Rye Wheat	0500000	Cereals			0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Muscle Fat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.2 mg/kg	Details
2,4-DB conjugates	Annex II	Muscle Fat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.2 mg/kg	Details
2,4-DB conjugates	Annex II	Olives for oil production Oil palms kernels Oil palms fruits Kapok Other oil fruits	0400000	Oilseeds and oil fruits	0402000	Oil fruits	0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Liver	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.4 mg/kg	Details
2,4-DB conjugates	Annex II	Kidney Edible offals (other than liver and kidney) Other commodities from goat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.1 mg/kg	Details
2,4-DB conjugates	Annex II	Liver	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.4 mg/kg	Details
2,4-DB conjugates	Annex II	Duck Geese Quail Other birds eggs	1000000	Products of animal origin - Terrestrial animals	1030000	Birds eggs	0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Almonds Brazil nuts Cashew nuts Chestnuts Coconuts Hazelnuts/cobnuts Macadamias Pecans Pine nut kernels Pistachios Walnuts Other tree nuts	0100000	Fruits, fresh or frozen and Tree nuts	0120000	Tree nuts	0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Chicken	1000000	Products of animal origin - Terrestrial animals	1020000, 1030000	Milk; Birds eggs	0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Linseeds Peanuts/groundnuts Poppy seeds Sesame seeds Sunflower seeds Rapeseeds/canola seeds Soyabeans Mustard seeds Cotton seeds Pumpkin seeds Safflower seeds Borage seeds Gold of pleasure seeds Hemp seeds Castor beans Other oilseeds	0400000	Oilseeds and oil fruits	0401000	Oilseeds	0.05 mg/kg	Details
2,4-DB conjugates	Annex II	Kidney Edible offals (other than liver and kidney) Other commodities from equine	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.1 mg/kg	Details
2,4-DB conjugates	Annex II	Muscle Fat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.2 mg/kg	Details
2,4-DB conjugates	Annex II	Muscle Fat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.2 mg/kg	Details
2,4-DB conjugates	Annex II	Muscle Fat	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.2 mg/kg	Details
2,4-DB conjugates	Annex II	Grapefruits Oranges Lemons Limes Mandarins Other citrus fruits	0100000	Fruits, fresh or frozen and Tree nuts	0110000	Citrus fruits		Details
2,4-DB conjugates	Annex II	Liver	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.4 mg/kg	Details
2,4-DB conjugates	Annex II	Kidney Edible offals (other than liver and kidney) Other commodities from bovine	1000000	Products of animal origin - Terrestrial animals	1010000	Commodities	0.1 mg/kg	Details

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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	Expressed As
silicic acid, magnesium-sodium-fluoride salt	37296-97-2	685	85950	yes	no	no	0.15 mg/kg				SML expressed as fluoride. Only to be used in layers of multi-layer materials not coming into direct contact with food.				As fluoride	Details

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Recycled Plastic Food Contact Materials

Recycled Plastic FCMs - Regulation (EU) 2022/1616

The list contains the Union list of authorised substances for the purposes of compositional requirements related to recycled plastic FCMs. The list is taken from Annex I to Commission Regulation (EU) No 10/2011. Recycled plastic FCMs shall comply with the requirements set out in Regulation (EU) No 10/2011. In addition, plastic waste inputs shall originate only from plastic materials and articles manufactured in accordance with Regulation (EU) No 10/2011.

Additive or PPA	Expressed As	FCM No	FRF applicable
yes	As fluoride	685	no	Details

legislation-obligation

legislation-obligation

Substance Regulatory Obligations

Confidential or not yet assessed substance

Active Implantable Medical Devices Directive - Hazardous Substances

Cosmetic Products Regulation, Annex III - Restricted Substances

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

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

Medical Devices Directive - Hazardous Substances

Annexes II, III, IV, VII - Defined & Temporary Maximum Residue Levels

FCM and Articles Regulation, Annex I - Authorised Substances

Recycled Plastic FCMs - Regulation (EU) 2022/1616

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