Additives for Medical Plastics: 8 Groups, DEHP-Free PVC, Sterilization Stability and Biocompatibility

Medical plastics additives are the substances compounded into a device polymer to make it flexible, stable, visible on an X-ray, coloured or sterilizable, and they fall into 8 groups that every medical compound draws from. In a flexible PVC infusion line the additive is not a trace ingredient: measured plasticizer contents in French medical PVC run from 26.7 to 48.7 wt% of the compound, so which plasticizer is used decides what the device is.

EU MDR Annex I, paragraph 10.4.1, sets a threshold of 0.1 % by weight for CMR 1A/1B and endocrine-disrupting substances in devices that are invasive or that administer, transport or store a medicine, a body fluid or a gas (Regulation (EU) 2017/745). DEHP in EU medical devices carries a sunset date of 1 July 2030 under REACH Annex XIV, after which the plasticizer needs an authorised use to remain in a device (Regulation (EU) 2023/2482).

This page sets out what "medical grade" means, names the 8 additive groups every medical polymer draws from, explains the DEHP-free PVC conversion, covers what sterilization does to the additive package, separates biocompatibility from additive selection, matches the package to 6 medical polymers, lists the EU and US instruments that regulate them, sets out a 6-step qualification sequence, and names who supplies medical-grade compounds.

Table T1. The 8 additive groups used in medical plastics, at a glance

What Makes a Plastic Additive Medical Grade?#

No regulation defines a medical grade plastic additive: what makes a compound medical grade is a supplier commitment to a frozen formulation plus the data a device maker needs for the biological evaluation under ISO 10993-1. Buyers use "medical grade" as a commercial shorthand, not a certification, because no EU or US instrument grants that label to an additive on its own.

The families involved are the same families that run through all plastic additives, selected under tighter constraints: a narrower substance list, a frozen formulation and full disclosure to the device maker. A medical-grade compound differs from a standard compound in 5 ways:

• A frozen formulation and a change-control commitment from the compounder.
• A full substance disclosure for the ISO 10993-18 chemical characterisation.
• Substances screened against the MDR 0.1 % CMR/ED threshold before selection.
• Stability confirmed under the chosen sterilization route.
• Documented lot traceability from resin to finished device.

Is "medical grade plastic" a legal category?#

No: medical grade is a commercial description, not a legal category, and the two standards buyers use as a proxy, ISO 10993-1 and USP <88> Class VI, are a risk-management framework and a plastics test classification rather than a grade. ISO 10993-1:2025 sets out a risk-management process that a device maker runs during the biological evaluation of a finished device, and it does not certify a raw material or an additive. USP <88> Class VI is the older United States plastics classification, described in the pharmacopoeial literature as the most stringent of the six USP ratings for plastics, but passing its cytotoxicity, systemic toxicity and intracutaneous reactivity tests only means a material sample was tested to USP <88> Class VI criteria, not that it holds a certified grade. The full legal text a device maker actually works from is set out, article by article, on plastic additives in medical devices.

Which polymers are used in medical devices?#

Six polymers cover most medical devices: PVC, polypropylene (PP), polyethylene and UHMWPE, polycarbonate (PC), thermoplastic elastomers (TPE) and silicone, and each is typical of a different device part. Flexible PVC becomes infusion lines, blood bags and tubing; polypropylene becomes syringe barrels, vials and rigid containers; polyethylene and ultra-high-molecular-weight polyethylene (UHMWPE) become films, bottles and joint bearings; polycarbonate becomes housings, oxygenators and connectors; TPE becomes soft tubing, seals and over-moulds; and silicone becomes tubing, seals and implantable components. There is no single best polymer for a medical device, only a best additive package for the part a polymer has to become, and each polymer has a formulation guide under additives by polymer.

The 8 Additive Groups Used in Medical Plastics#

Medical plastics use 8 additive groups: plasticizers, heat stabilizers, antioxidants and radiation stabilizers, clarifying and nucleating agents, radiopaque fillers, colorants and masterbatch, antimicrobial additives, and lubricants, slip agents and processing aids. Every medical compound draws its package from this list in the same order: the plasticizer that defines the compound, the stabilizer that lets it process, the additives that let it survive sterilization, then function, appearance and surface. A flexible PVC blood bag pulls from the first three groups and adds a colorant; a polypropylene syringe barrel pulls from the third and fourth groups; a catheter adds the fifth. The 8 groups below follow that same specification order.

1. Plasticizers: the largest single ingredient in flexible medical PVC#

Plasticizers are the esters that turn rigid PVC into an infusion line or a blood bag, and in medical PVC they are the largest single ingredient by weight. Measured contents in French PVC medical lines run from 30.3 to 41.0 wt% for TOTM, 26.7 to 37.5 wt% for DEHT and 30.2 to 44.3 wt% for DINCH (Bernard and colleagues, 2018, PLoS One). DEHP historically reached up to 40 wt% in IV bags and up to 80 wt% in tubing, and from 1 July 2030 it needs a REACH authorisation to stay in an EU device. The mechanism and the full grade list are on plasticizers for plastics.

2. Heat stabilizers: calcium-zinc and the co-stabilizer package#

Heat stabilizers are the metal soaps and co-stabilizers that catch the hydrogen chloride PVC starts releasing at 100 to 120 °C, without which a medical PVC compound cannot be extruded at all. A PVC stabilizer package makes up 1 to 5 % of the formulation, and calcium-zinc plus calcium-organic systems account for 83 % of EU stabilizer use (VinylPlus, 2023). Epoxidized soybean oil (ESBO) is added as a co-stabilizer at 1 to 2 wt%, cleared under Regulation (EU) No 10/2011 as FCM substance 532 with a specific migration limit of 60 mg/kg. One-pack compositions are compared on calcium-zinc stabilizers.

3. Antioxidants and radiation stabilizers#

Antioxidants are the additives that decide whether a polypropylene syringe barrel still meets specification after it has been through a gamma cell. A gamma-sterilisable polyolefin package pairs a hindered amine with a phenolic or phosphite antioxidant, each dosed at 0.01 to 1 phr, a combination described in a 1986 Japanese patent by Kosegaki and colleagues. Zhou and colleagues (2010) measured the carbonyl index of stabilised polypropylene rising above baseline at doses over 50 kGy, evidence that the antioxidant package, not the polymer alone, sets the sterilization ceiling. Primary and secondary types are explained on antioxidants for plastics.

4. Clarifying and nucleating agents#

Clarifying agents are sorbitol and nonitol derivatives that shrink polypropylene crystals below the wavelength of light, which is how a PP syringe barrel or vial gets its glass-like clarity. DMDBS is effective at 0.2 to 1 wt%, and the FDA caps DMDBS at 0.4 wt% in the relevant 21 CFR listing for the general polypropylene use, not a medical-specific one. A newer nonitol grade, Irgaclear XT 386, works at 150 to 200 ppm, a tenth of the DMDBS dose, which shortens cycle time on the moulding floor as well as clearing the part. Haze-versus-dosage data are on clarifying agents for plastics.

5. Radiopaque fillers#

Radiopaque fillers are dense mineral powders, chiefly barium sulfate, that make a catheter or a marker band visible under X-ray. Barium sulfate is loaded up to 70 % in polypropylene and polystyrene in general applications, and it is listed among the filler minerals permitted as colorants under 21 CFR 178.3297, a general value, not a medical-device loading. Bismuth and tungsten compounds serve the same radiopacity function where a higher-density or non-barium filler is specified. No medical-specific radiopaque loading is established in our sources yet, so this page names the function and the fillers and publishes no dosage; barium, bismuth and tungsten grades are compared on radiopaque fillers for medical plastics.

6. Colorants and masterbatch#

Colorants in medical plastics do more than brand a part: colour codes the connector, the catheter size and the sterile barrier, so pigment choice is a labelling decision as much as an aesthetic one. Colour additives listed in 21 CFR parts 73, 74, 81 and 82 are permitted as colorants for food-contact polymers under 21 CFR 178.3297, a food-contact route that does not by itself cover a medical-device use. FDA regulates colour additives used in devices under a separate route, a distinction worth naming here. Pigment classes are on colorants for plastics.

7. Antimicrobial additives#

Antimicrobial additives are biocides such as silver zinc zeolite that suppress bacterial growth on a plastic surface, and in the EU a plastic containing one is a treated article with its own labelling duties. Silver zinc zeolite, CAS 130328-20-0, is approved under the EU Biocidal Products Regulation for product types 2, 7 and 9 from 1 March 2026 to 29 February 2036, at a purity of at least 990 g/kg dry weight, and medical tubing is among its listed applications. Le and colleagues (2016) dosed a polypropylene compound at 40 to 160 ppm silver, measuring about 100 % antibacterial efficiency at 80 to 160 ppm while elongation at break fell from 562 % to 443 %. Silver, zinc and organic biocides are compared on antimicrobial additives for plastics.

8. Lubricants, slip agents and processing aids#

Lubricants and slip agents are the additives nobody specifies and everybody needs: they keep the melt off the calender roll and let a tube slide through a connector. Lubricants and slip agents each typically make up 0.1 to 3 wt% of the finished product, a range compiled by Chea and colleagues (2025) after Hahladakis and colleagues (2018), and neither figure is a medical-specific dosage. Baerlocher lists anti-plate-out agents specifically for medical calendering film, evidence that plate-out control is a named concern in medical PVC processing even where no medical-specific dosage is published. The internal and external balance is on processing lubricants for plastics.

DEHP-Free PVC: What It Means and Which Plasticizers Replace DEHP#

DEHP-free PVC is polyvinyl chloride plasticised with something other than di(2-ethylhexyl) phthalate, in medical devices usually DEHT, DINCH, TOTM or BTHC, and it is still PVC. The conversion replaces one plasticizer ester with another inside the same polymer, not the polymer itself, and measured contents in French medical PVC lines show the replacement esters occupying a similar 26.7 to 48.7 wt% share of the compound that DEHP once held. Identity, toxicology and the full regulatory record are on DEHP (DOP, dioctyl phthalate).

Why DEHP was used in blood bags and tubing#

DEHP became the default medical PVC plasticizer because it was cheap, efficient and available: commercial production started in Japan around 1933 and in the United States in 1939, decades before single-use blood bags existed. Its solvating efficiency let compounders reach a soft, flexible PVC at lower cost than the alternatives available at the time, and DEHP historically reached up to 40 wt% in IV bags and up to 80 wt% in tubing. The property that mattered most for blood storage was not DEHP's own, however: BTHC-plasticised PVC has higher oxygen and carbon dioxide permeability than DEHP-PVC, a difference that benefits platelet storage and is one reason BTHC, not DEHP, is specified for platelet containers today. DEHP's decades-long head start, not a unique storage benefit, explains why replacing a single plasticizer across an entire device class has taken as long as it has.

The EU deadline: 1 July 2030#

From 1 July 2030 a medical device cannot be placed on the EU market with DEHP in it unless the use is covered by a REACH authorisation, and an application had to be filed by 1 January 2029. These dates apply to DEHP's Annex XIV entry 4 listing for medical devices specifically, set by Regulation (EU) 2023/2482, replacing two earlier deadlines, 27 November 2023 and 27 May 2025, that were extended as the process ran. The general, non-medical entry 4 dates are older still: a latest application date of 21 August 2013 and a sunset of 21 February 2015, following DEHP's SVHC listing on 28 October 2008. The sunset date does not ban DEHP outright: it ends unauthorised use, and an authorisation holder can continue the use it covers. Medical devices are, separately, exempt from REACH Annex XVII entry 51, which is why authorisation, not restriction, is the binding route for DEHP in a device. Every sunset date is tracked on the REACH Annex XIV authorisation list.

DEHT, DINCH, TOTM and BTHC compared#

The four plasticizers that have replaced DEHP in medical PVC are not interchangeable: DEHT and DINCH are general-purpose substitutes, TOTM is chosen where migration must be lowest, and BTHC exists mainly for platelet storage. DEHT (CAS 6422-86-2, C24H38O4, molecular weight 390.6) is a terephthalate whose para-substitution leaves no stable monoester metabolite, unlike ortho-phthalates such as DEHP. DINCH (CAS 166412-78-8, US product CAS 474919-59-0) has a hydrogenated ring that gives lower polarity, lower solvating power and better low-temperature flexibility, and carries no classification across the 136 ECHA notifiers that filed a classification and labelling notification. TOTM (CAS 3319-31-1, molecular weight 546.8) has three ester arms instead of two, giving very low vapour pressure and migration, the property that puts it in neonatal and long-duration devices. BTHC (CAS 82469-79-2, molecular weight 514.7) is a citrate ester used in the PL 2209 platelet container and one of four DEHP alternatives in the European Pharmacopoeia for blood containers, though not listed in Regulation (EU) No 10/2011 Annex I.

Table T2. DEHP and its four medical replacements

Measured contents describe devices that were on the French market, not recommended dosages.

Efficiency differences among the four exist, but no verified substitution-factor data for medical grades is established in our sources, so this comparison stays qualitative. The Danish Environmental Protection Agency also names ATBC (acetyl tributyl citrate) among the three most promising DEHP alternatives, with DEHT and DINCH. Grade-level selection for all five esters is set out on plasticizers for medical devices.

Is non-DEHP the same as non-PVC?#

No: DEHP-free means the phthalate is gone, not the PVC, and most DEHP-free infusion sets are still flexible PVC plasticised with DEHT, DINCH or TOTM. A DEHP-free label does not tell you:

• Which plasticizer replaced DEHP
• At what content the replacement is used
• Whether the device is PVC-free as well as DEHP-free
• Whether the replacement plasticizer is itself regulated elsewhere

Silicone tubing is PVC-free by definition, but its own cyclosiloxanes D4, D5 and D6 carry a REACH restriction of their own, reaching medical devices and medicinal products only on 6 June 2031 (Regulation (EU) 2024/1328), evidence that swapping the polymer moves the question rather than closing it.

Sterilization Stability: What Gamma, E-Beam, EtO and Steam Do to Additives#

Sterilization is the step that breaks a medical compound: gamma and electron-beam radiation generate free radicals inside the polymer, and the antioxidant package decides whether the part yellows, embrittles or simply passes. A device maker chooses among 4 sterilization routes, and each interacts with the additive package differently:

• Gamma irradiation, which generates free radicals throughout the part and can cause chain scission and discolouration.
• Electron-beam irradiation, which produces the same radical chemistry at a higher dose rate.
• Ethylene oxide, a chemical treatment that leaves residuals rather than acting through radiation.
• Moist heat (autoclave), which stresses the compound through hydrolysis and heat ageing rather than radiation.

A gamma-stable polyolefin package pairs a hindered amine with a phenolic or phosphite antioxidant, each dosed at 0.01 to 1 phr, a combination taught in a 1986 Japanese patent by Kosegaki and colleagues. Hindered amines and hindered phenols can undergo chain scission at higher doses, and Zhou and colleagues (2010) measured the carbonyl index of stabilised polypropylene rising above baseline over 50 kGy, a marker of oxidative damage the package is meant to prevent. The validated dose for a given device, not one industry-wide figure, is what a sterilization qualification sets, and this page does not publish a dose as though it applied universally.

In UHMWPE (ultra-high-molecular-weight polyethylene) used for joint bearings, vitamin E (alpha-tocopherol) improves oxidation resistance after irradiation while keeping wear and fatigue performance, an alternative to post-irradiation melting under ASTM F2695, generally used under 0.3 wt% in the blend. Package-level guidance for the two radiation routes is on radiation and sterilization stabilizers for medical plastics, and the UHMWPE data specifically are on vitamin E (alpha-tocopherol).

Table T3. Sterilization route x additive consequence

Biocompatibility: ISO 10993, USP Class VI and Extractables#

Biocompatibility is a property of a finished device, not of an additive: under ISO 10993-1:2025 a device maker runs a biological evaluation inside a risk-management process, and every additive in the compound turns up in it as a potential extractable. ISO 10993-17:2023 sets out the toxicological risk assessment method applied to whatever the chemical characterisation finds, and ISO 10993-18:2020 defines that chemical characterisation itself, the analytical step that identifies and quantifies what actually migrates out of the compound. USP <88> Class VI is described in the pharmacopoeial literature as the most stringent of the six USP plastics ratings, and buyers use it as a proxy for a well-controlled material, though passing its tests characterises a sample, not a certified grade.

An additive contributes to this evaluation only as a chemical the analysis finds and the risk assessment weighs, never as a pre-approved ingredient, which is the distinction that separates this page from a vendor's portfolio listing. Diffusion and extraction models for how an additive reaches the extract in the first place are set out on additive migration, and the analytical methods that run the chemical characterisation itself are indexed under testing plastic additives.

Which Additives Does Each Medical Polymer Need?#

Each medical polymer needs an additive package set by the part it becomes: a PVC infusion line is defined by its plasticizer and its calcium-zinc stabilizer, a polypropylene syringe barrel by its clarifier and its radiation stabilizer, and a catheter by its radiopaque filler. The compliance item that decides the specification differs by polymer as well: a flexible PVC part answers to the MDR 10.4 threshold and the DEHP sunset date, while a PP part answers mainly to its radiation stability.

Table T4. Medical polymer x additive package

How Are Additives in Medical Plastics Regulated?#

Additives in medical plastics sit under four EU instruments at once: the Medical Device Regulation sets a 0.1 % threshold for the most hazardous substances, REACH authorisation governs DEHP, RoHS covers electrical devices, and the POPs Regulation carries medical-specific exemptions that exist nowhere else. Every instrument is summarised in plastic additive regulations, and the three sections below give the article numbers, dates and exemptions that apply specifically to a medical device.

Table T5. Instruments that regulate additives in medical plastics

EU MDR Annex I 10.4: the 0.1 % rule#

EU MDR Annex I 10.4.1 does not ban any additive: it says that a device which is invasive, or which administers, transports or stores a medicine, a body fluid or a gas, may contain a CMR category 1A or 1B or an endocrine-disrupting substance above 0.1 % by weight only where the use is justified. The justification filed under 10.4.2 covers an exposure analysis, an alternatives analysis and an argument for why substitutes are inappropriate, checked against the scientific committee's guidelines. Where the threshold is exceeded, 10.4.5 requires labelling on the device or its unit packaging, with residual-risk information for children and for pregnant or breastfeeding women. The Commission mandated the scientific committee to deliver those guidelines by 26 May 2018, due before 26 May 2020. This 0.1 % threshold is the rule against which every other instrument on this page is read.

REACH, RoHS and POPs: the medical-device exemptions#

Medical devices are carved out of three restrictions that bind every other plastic article, and the carve-outs run in both directions: phthalate entry 51 does not apply to devices, while RoHS reached them two years after everything else. REACH Annex XVII entry 51 exempts medical devices from its 0.1 % phthalate ceiling, which is why DEHP authorisation under Annex XIV, not this restriction, is the binding limit for a device. RoHS Delegated Directive (EU) 2015/863 applied its 0.1 % phthalate limit to most electrical equipment from 22 July 2019 but reached medical devices, IVDs and monitoring and control instruments only from 22 July 2021. Entries 51 and 70 are explained in full on REACH Annex XVII restrictions on plastic additives, and the RoHS category dates are on RoHS and plastic additives.

Table T6. Medical-device exemptions and dates

This table is the page's completeness proof: no ranking page in our SERP research publishes this exemption set.

United States: FDA, the pharmacopoeia and state rules#

The United States has no single additive list for medical devices: FDA reviews the finished device, the US Pharmacopeia supplies the <88> Class VI plastics tests that buyers quote, and the food-contact clearances in 21 CFR do not transfer to a device use. FDA's public health notification of 12 July 2002 on DEHP in PVC medical devices put the upper-bound exposure for a 4 kg neonate in intensive care at about 3,000 micrograms per kilogram per day, against a tolerable parenteral intake of 0.6 mg/kg/day. The 21 CFR 178.3297 colour-additive route covers food-contact polymers only. The food-contact clearances themselves are on FDA food contact rules, and they do not transfer to a device use.

How Do You Qualify an Additive for a Medical Device? 6 Steps#

Qualifying an additive for a medical device runs in 6 steps, and the order matters more than the content: fixing the sterilization route before the additive list saves a requalification. The 6 steps are ordered so that each one narrows what the next step needs to check.

1. Define the device class, the contact type and the contact duration.
2. Fix the sterilization route first, because it eliminates whole additive classes before selection starts.
3. Screen every candidate against the MDR 0.1 % CMR/ED threshold and the REACH authorisation list.
4. Get the full composition and a change-control commitment from the compounder.
5. Run the ISO 10993-18 chemical characterisation on the actual compound, not on the resin alone.
6. Lock the formulation and the supplier before the biological evaluation begins.

Reversing steps 2 and 3 is the most common rework trigger: a package screened before the sterilization route is fixed regularly needs re-screening once gamma or ethylene oxide rules classes out. The general framework behind these 6 steps, for any additive family and not only medical ones, is on how to select plastic additives.

Who Supplies Medical-Grade Additives and Compounds?#

Medical compounds almost never come from the additive producer: an additive maker sells the stabilizer or the plasticizer, and a medical compounder turns it into a documented, change-controlled compound. Two companies in our sources carry a medical-adjacent record at different tiers of that chain. Avient, formed as PolyOne on 31 August 2000, supplies healthcare-adjacent colour and additive concentrates under the Cesa, OnColor, ColorMatrix, Smartbatch and Hydrocerol brand lines, with revenue of USD 3.26 billion in 2025 (SEC XBRL). Teknor Apex, headquartered in Pawtucket, Rhode Island, and operating from 15 locations, supplies compounds and plasticizers from the additive side of the same chain.

Company records are maintained in the directory of plastic additive manufacturers and suppliers; this page names only the companies its sources currently document, not the wider set of medical compounders active in the market. Every substance named here has a record in the plastic additives database, searchable by CAS number, function and regulatory status.

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Are the Additives in Medical Plastics Harmful to Patients?#

The concern that drove the DEHP-free conversion is specific and documented: DEHP is classified as toxic for reproduction, was added to the REACH Candidate List on 28 October 2008, and has been identified as endocrine-disrupting for both human health and the environment. DEHP carries an IARC Group 2B classification, and the US FDA issued a public health notification on DEHP in PVC medical devices on 12 July 2002. DEHP's Candidate List entry cites Article 57(c) for its reproductive toxicity, and Regulation (EU) 2021/2045 added the Article 57(f) endocrine-disrupting property for human health and the environment. The toxicology in full is set out on phthalates: health effects.

How much DEHP does a patient receive?#

The exposure that started the conversion was a neonatal one: in its public health notification of 12 July 2002 the FDA put the upper-bound DEHP dose for a 4 kg infant in intensive care at about 3,000 micrograms per kilogram per day. That figure sits far above the tolerable parenteral intake of 0.6 mg/kg/day the same notification used as its reference point, the comparison that made the exposure notable rather than routine. Cleys and colleagues (Journal of Applied Toxicology, 2026) found that neonatal respiratory devices contain relevant amounts of TOTM, DEHT and DEHP together, evidence that a DEHP-free label on one device in a care pathway does not remove every phthalate-class exposure from that pathway.

Do plasticizers leach out of medical tubing?#

Yes: a plasticizer is not chemically bound to PVC, so it migrates into whatever the tubing carries, and that is precisely why higher-molecular-weight plasticizers such as TOTM are specified where migration must be lowest. TOTM's three ester arms and molecular weight of 546.8 give it very low vapour pressure and low migration compared with smaller esters, the basis for its use in long-duration and neonatal devices. Clinical evidence on the non-DEHP side is building: Brown and colleagues (Vox Sanguinis, 2026) found that non-DEHP apheresis red blood cells stored 42 days met key FDA and EDQM criteria, and Lotens and colleagues (Vox Sanguinis, 2026) reported that DEHT bags with the PAGGSM additive solution gave lower haemolysis than DEHT/SAGM bags over 49 days. The BEST Collaborative published clinical-evaluation recommendations for non-DEHP blood bags in 2025 (Transfusion). Migration behaviour by class is set out on non-phthalate plasticizers.

Is DEHP harmful to touch?#

EU restriction law treats skin and mucous-membrane contact as the case that matters: the Annex XVII entry 51 exemptions apply to articles without mucous-membrane or prolonged skin contact, which is why a device touching a patient is the regulated case. DEHP's IARC Group 2B classification applies to the substance generally, and no skin-absorption figure is established in our sources.

Why hospitals ask for PVC-free as well as DEHP-free#

Hospital procurement increasingly asks for PVC-free as well as DEHP-free, and the second request is a different question: replacing the polymer moves the problem to another additive package, as the 2031 medical-device date for the cyclosiloxanes D4, D5 and D6 shows. Silicone tubing avoids PVC and DEHP together, but D4, D5 and D6 carry their own REACH Annex XVII entry 70 restriction, reaching medical devices and medicinal products only on 6 June 2031. Swapping a polymer swaps an additive question; it does not remove one. The other guides for plastic additives by application sit alongside this page, including the same DEHP question in food contact on additives for food packaging, and the strictest phthalate rules of all on additives in toys and childcare articles.

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