New progress in the evaluation of phthalates in food contact materials in Europe and the United States

Phthalates are widely used plastic plasticizers in food packaging materials, toys, plastic gaskets and hoses for machinery and equipment, and many other products
.
At the same time, risk research on such substances is also ongoing
.
Recently, the European Union and the United States have made new progress in the risk research of phthalates in food contact materials
.
 

EU side

On May 12, 2022, the European Food Safety Authority (EFSA) issued a "Risk assessment of phthalates, structural analogs and alternative substances that may be used as plasticizers in materials and articles intended to come into contact with food.
" Identification and Prioritization" and "Exposure Assessment Procedures for Risk Assessment of Phthalates, Structural Analogs and Alternative Substances as Possible Plasticizers in Materials and Articles Intended for Food Contact" Version; clarifies that the assessment of EU consumer exposure to plasticizer substances should be carried out in accordance with the requirements of the European Commission
.

The final version of the scientific opinion is essentially the same as the draft released in November 2021, with a few additional substances added to the prioritization plan
.
Provides an overview of substances identified for use as plasticizers in food contact materials and provides more detail in the process of creating a final list of substances for risk assessment than the draft
.
The European Food Safety Authority (EFSA) classifies these substances into high, medium or low priority groups for further risk assessment
.

The document also pointed out that according to the European Commission's investigation of relevant stakeholders and the monitoring results of member states, the non-phthalate plasticizers in the list have largely replaced the five commonly used phthalate plasticizers (DBP).
, BBP, DEHP, DINP and DIDP)
.

American side

On May 19, 2022, the U.
S.
Food and Drug Administration (FDA) responded to three petitions for phthalates related to food contact substances
.
At the same time, a request for information on available safety data for certain phthalates in food contact applications was issued
.

There is some overlap between the phthalates covered in the three petitions.
, which responded differently to each petition:

(1) For the petition filed by the Flexible Vinyl Alliance on July 3, 2018 to remove 25 phthalates as food contact substances:

◆ The U.
S.
Food and Drug Administration (FDA) has taken action - withdrawing phthalates already authorized under the Food Additives (Food Contact Materials) regulations, and these phthalates It is industrially deprecated
.

(2) For food additive petitions submitted by multiple public interest groups, it is recommended that 28 phthalates be grouped into one category and that these substances be removed from the FDA food additive regulations
.

◆ The U.
S.
Food and Drug Administration (FDA) rejected and explained that the petition did not contain a basis for grouping the 28 phthalates, nor did it prove that the proposed portion of phthalates No longer safe for use as a food additive now approved
.

(3) Another citizen petition rejected by the U.
S.
Food and Drug Administration (FDA) asked the FDA to revoke the approval of 5 phthalates and ban the other 8 phthalates
.

◆ With regard to the citizen petition, the FDA stated that "there is no scientific data or information in the petition to justify these actions
.
" 

In addition, the U.
S.
Food and Drug Administration (FDA) has issued a request for information to the public that provides and supplements the following specific current uses, levels of use, dietary exposure, and Secure Data
.
FDA will use this information to conduct a safety assessment of dietary exposure to phthalates permitted for food contact use
.
Comments on the request for information should be submitted by July 19, 2022
.

· Diisooctyl phthalate (DINP)

· Diisodecyl phthalate (DIDP)

· Di(2-ethylhexyl) phthalate (DEHP)

· Dicyclohexyl phthalate (DCHP)

· Butyl terephthalate (BPBG)

· Diethyl phthalate (DEP)

· Ethyl glycolate (EPEG)

· Diisooctyl phthalate (DIOP)

Phthalates are already considered a class of risk substances, and many different kinds of phthalates have been included in the scope of risk assessment
.
The prohibition of some phthalates has put forward higher requirements for food contact materials or packaging manufacturers.
Relevant enterprises need to pay attention to the regulatory trends in various countries and regions in real time, and only find a reasonable response on the basis of fully understanding the requirements.
measures in order to produce and manufacture products that meet the requirements
.