European Commission proposes updates to medical device phthalates guidelines
Regulatory News | 26 March 2024 |
European Commission headquarters in Brussels. (Source: iStock)
The European Commission has launched a public consultation on an update to its guidelines on benefit-risk assessments for medical devices containing phthalates. This is the first time the Commission has proposed updating the guidelines since they were released in 2019.
The proposed update was published on 21 March by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The guidelines must be updated every five years under the EU Medical Devices Regulation (MDR). (RELATED: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates, Regulatory Focus 28 March 2019)
“Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED),” the Commission said.
It noted that while the guidelines apply to medical device manufacturers, they also apply to other stakeholders, such as notified and regulators. It further stated that manufacturers should use the guidelines to describe how they have evaluated potential alternative materials that can be used instead of phthalates and how that affects the design of their product and the conditions they are intended to treat.
The guidelines also detail the methodology medical device manufacturers should use to perform risk-benefit analysis to justify keeping certain CMR/ED phthalates over the 0.1% threshold in their products or parts that make up their products. The Commission also noted that the document can be used to evaluate the risk-benefit of other CMR/ED chemicals in medical devices.
Among the major updates proposed in the guidelines, the committee has updated the description of chemical substances categorized as phthalates as esters of phthalic acid.
“Phthalates are a group of substances widely used in medical devices as plasticizers,” the guidelines stated. “They are a family of chemicals with different chemical structures: phthalates are esters of the phthalic acid, i.e. benzene dicarboxylic acid.”
The guidelines also updated the methods and framework sections and included new information on classifying endocrine-disrupting hazards based on regulations.
“Recently, the Commission Delegated Regulation (EU) 2023/707 amended Regulation (EC) No 1272/2008 (CLP, classification, labeling and packaging of substances and mixtures), introducing two hazard categories for endocrine disruptors for human health with Category 1 considering known or presumed endocrine disruptors for human health, and Category 2 considering suspected endocrine disruptors for human health,” the guidelines stated.
Stakeholders can comment on the proposed updates to the guidelines on the Commission’s website until 28 April. It also plans to hold a public hearing on the topic on 11 April in Brussels.
Public consultation
The proposed update was published on 21 March by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The guidelines must be updated every five years under the EU Medical Devices Regulation (MDR). (RELATED: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates, Regulatory Focus 28 March 2019)
“Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED),” the Commission said.
It noted that while the guidelines apply to medical device manufacturers, they also apply to other stakeholders, such as notified and regulators. It further stated that manufacturers should use the guidelines to describe how they have evaluated potential alternative materials that can be used instead of phthalates and how that affects the design of their product and the conditions they are intended to treat.
The guidelines also detail the methodology medical device manufacturers should use to perform risk-benefit analysis to justify keeping certain CMR/ED phthalates over the 0.1% threshold in their products or parts that make up their products. The Commission also noted that the document can be used to evaluate the risk-benefit of other CMR/ED chemicals in medical devices.
Among the major updates proposed in the guidelines, the committee has updated the description of chemical substances categorized as phthalates as esters of phthalic acid.
“Phthalates are a group of substances widely used in medical devices as plasticizers,” the guidelines stated. “They are a family of chemicals with different chemical structures: phthalates are esters of the phthalic acid, i.e. benzene dicarboxylic acid.”
The guidelines also updated the methods and framework sections and included new information on classifying endocrine-disrupting hazards based on regulations.
“Recently, the Commission Delegated Regulation (EU) 2023/707 amended Regulation (EC) No 1272/2008 (CLP, classification, labeling and packaging of substances and mixtures), introducing two hazard categories for endocrine disruptors for human health with Category 1 considering known or presumed endocrine disruptors for human health, and Category 2 considering suspected endocrine disruptors for human health,” the guidelines stated.
Stakeholders can comment on the proposed updates to the guidelines on the Commission’s website until 28 April. It also plans to hold a public hearing on the topic on 11 April in Brussels.
Public consultation
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