dehp free europe

  • Lifolit soft PVCNon phthalate and DEHP free PVC

    Non phthalate plasticizer. All compounds are DEHP free. Conform to EN 71/3 for toys. Good UV resistance and weather proofing. Crystal clear, translucent, natural or colour compounded grades. Foamed grades up to a density of 0.45g/cm3. Antistatic and conductive grades available. Polymer blends.

  • Determining alternatives to DEHP for PVC medical devices

     · In a comprehensive European 1 study, DEHP is reported to have a NOAEL (no observable adverse effect level) of 4.8 milligrams per kilogram of body weight, while TOTM has a NOAEL of 100 milligrams (see table). By comparison, DOTP is listed at milligrams, making it 100 to 140 times safer than DEHP for rodents and 5 to 7 times safer than TOTM.


     · - European Commission, Directorate-General for Health & Consumers, SCENHIR, Opinion on the safety of medical devices containing DEHP plasticized PVC or other plasticizers on neonates and other groups possibly at risk, 6 February, 2008 . Title Microsoft Word

  • Preventing Harm from Phthalates, Avoiding PVC in

     · DEHP is part of a family of chemicals called phthalates. It is the most widely used phthalate as well as the phthalate most widely found in the environment. 90% of DEHP consumed in Europe is used as a plasticiser in polymers, mainly PVC. PVC softened with DEHP

  • Europe Four Phthalates added to RoHS 2 List of Restricted

     · On 4 June 2015, Directive (EU) 2015/863 [1] was published in the Official Journal of the European Union, adding four phthalates DEHP, DBP, BBP and DIBP to the list of restricted substances in Annex II of the RoHS 2 Directive 2011/65/EU. The list now contains a total of 10 substances 4 heavy metals, 2 flame retardants and 4 phthalates.

  • bis (2-ethylhexyl) phthalate (DEHP)

     · 2009). In the case of DEHP, this transfer can be illustrated by the following figures and facts in Western Europe, DEHP represents nowadays (2008 figures) only ca. 18% of the overall consumption of plasticisers, when DINP, DIDP and DPHP10 represent together ca. 65% (ECPI workshop, 2009 CEFIC, 2010) in

  • 2017 regulatory update on DEHP in medical devices

     · 2017 regulatory update on DEHP in medical devices. 29/06/2017. A lot of things are happening in the world of plasticisers and medical devices. In fact, it seems as if 2017 will be a decisive year for the use of DEHP in PVC-based medical devices. In an interview filmed at PVC 2017 in Brighton, Vice President of Regulatory Affairs/Advocacy at


     · PVC/DEHP phase-out is possible anywhere in Europe Model hospitals show how to succeed European healthcare institutions and hospitals using PVC-free medical devices Austria » Vienna Hospital Association (18 Hospitals, nursing homes, geriatric care centres) A product catalogue listing approximately 630 alternative

  • Plasticizers What is the difference between DEHT and

     · Concerns about the potential risk of DEHP have led most companies to replace DEHP with DEHT. DEHT is its main replacement which is free from phthalates. It is widely available and tested, and has a comprehensive toxicological portfolio, which indicates that it can be used in toys, beverage packaging and medical devices (more on this topic can

  • Regulation of DEHP Health Care Without Harm

    Regulation of DEHP. In the last few years, a number of government agencies and expert panels in Europe, the US, Canada, and Japan have reviewed the safety of DEHP, used to soften PVC medical devices. Each of these agencies and expert panels has found that DEHP exposure from some medical procedures may pose a risk to patients' health.

  • Final opinion on DEHPPublic HealthEuropean

     · Final opinion on DEHP. The main focus of this Opinion, which is an update of the 2008 SCENIHR Opinion, is on the potential risk for patients exposed to DEHP or similar plasticising compounds leaching from medical devices. Exposure of the general population to plasticizers has also been addressed. The assessment also includes information on

  • Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP

     · Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices Center for Devices and Radiological Health U.S. Food and Drug Administration

  • Phthalate Free PVCRegulations Manufacturers Need to

     · The EU has its own, similar, restrictions on phthalates in consumer and children’s products. DEHP, DBP, and BBP are banned for use over 0.1% in the EU in toys and childcare articles, and DINP, DIDP, and DnOP are prohibited only in toys and childcare articles that can be placed in the mouth. Current proposals and potential regulations


     · 100%. DEHP metabolic profiles in humans are different when compared to rats. DEHP metabolites (MEHP [mono(-2-ethylhexyl) phthalate] and oxidised derivatives), which are biologically active, are excreted in rat urine mostly as unconjugated forms (87.4% in free form). In contrast, in humans, DEHP is excreted mostly as glucuronides (87.7%), which lack

  • Directive (EU) 2015/863 Amends EU RoHS to Restrict 4

     · Directive (EU) 2015/863 Amends EU RoHS to Restrict 4 New Phthalates DEHP, BBP, DBP and DIBP. Little Pro on . On 4 June 2015, the EU commission has published a new Directive (EU) 2015/863 to amend Annex II to EU RoHS 2 (Directive 2011/65/EU) to add the following 4 phthalates onto the list of restricted substances.. Bis(2-Ethylhexyl) phthalate (DEHP) max 0.1%

  • Market surveillance of PVC medical devices presented

     · Certain phthalates are classified in Europe as toxic to reproduction. This is the case especially of bis(2‐ ethylhexyl) (DEHP) which is classified as toxic to reproduction of category 1B according to Regulation (EC) 1272/20081. DEHP is used in the manufacture of certain medical devices.


     · the European Union (EU) use DEHP or prepara ­ toi ns that contain DEHP (European Commissoi n, 2008). he European Commission reported that 1 million tonnes of DEHP were used in Europe in 2000 (IUCLID DataBase, 2000). DEHP was irst used commercially in the USA in 1949. During the period 1950–54, its production in the USA was 106 thousand

  • DEHP and Other PhthalatesDymax

    Di(2-ethylhexyl) phthalate (DEHP) is a plasticizer added to polyvinyl chloride (PVC) to make the normally rigid plastic more flexible. Many companies, especially those in the medical device industry, are requiring suppliers to inform them of DEHP or other phthalate use.

  • Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP

     · Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released from PVC Medical Devices Center for Devices and Radiological Health U.S. Food and Drug Administration

  • Emissions of DEHP-free PVC flooring.AbstractEurope

     · Since the EU banned the use of phthalates in sensitive applications, the market is shifting to use DEHP‐free and alternative types of plasticisers in PVC products. However, data on emissions from DEHP‐free PVC floorings are scarce. This study aimed at assessing the surface and bulk emissions of two DEHP‐free PVC floorings over three years.

  • European Union further restricts four phthalates

     · The European Union is a step closer to prohibiting the use of four phthalates in consumer products. The Socio-Economic Analysis Committee of the European

  • The Blood

    Why difficult to exchange PVC and DEHP? The reasons why there are no PVC-free blood bags on the market are several. We need to store blood and the red blood cells are stabilized by DEHP causing less hemolysis. The blood bag is a complex product with The blood bag is a life-saving product “Not profiterable for the producers”


     · The global production of DEHP in 1994, was estimated to be between 1 and 4 million tonnes/year. The production volume of DEHP in Western Europe was 595,000 tonnes/year in 1997. Recent information from industry (May 2005) shows that the use of DEHP in the EU has decreased to 221,000 in 2004, whilst the use of the phthalates

  • DEHP Labeling Medical DevicesElsmar Cove Quality and

     · What Specific Tests are Required to Label a Device as being DEHP Free EU Medical Device Regulations 5 Jun 21, 2012 H Illegal use of Plasticizer (DEHP & DINP) in Food Food SafetyISO 22000, HACCP (21 CFR 120) 1 May 28, 2011 Naturally Occurring DEHP in PVC TubingStatements about tubing being DEHP-Free EU Medical Device Regulations

  • What is DEHP? Where is it used? Why is it used? U.S. Plastic

    Currently, DEHP cannot be used in food contact products, such as tubing, in Europe. It is expected that this regulation will impact North American based food companies in the near future. Additionally, consumer and environmental advocacy groups have aggressively attacked the use of DEHP in the mainstream media.

  • DEHP phthalates in medical devicesGOV.UK

     · Phthalates are chemicals added to polyvinyl chloride (PVC) plastic to make it softer and more flexible.Di (2-ethylhexyl) phthalate (DEHP) is the type used the most in medical devices such as

  • The Weight of Evidence Introduction on DEHP

     · producers to develop DEHP-free alter-native high-quality products and to rec-ommend their use to customers, espe-cially the high-risk patient groups men-tioned above.9 Recommendations to Limit the Use of DEHP Outside of EU Proposition 65 California Proposition 65 The Office of Environmental Health Hazard Assessment (OEHHA) of the California

  • MHRA Publishes Guidance Relating to DEHP Phthalates in

     · European Commission Report concerning DEHP Phthalates On 25 June 2015, the Scientific Committee on Emerging and Newly-Identified Health Risks (commonly referred to as, the “SCENIHR”) from the European Commission adopted an updated report in relation to “The safety of medical devices containing DEHP plasticized PVC or other plasticizers on