September 2026

Following the 2020 CARES Act, the United States (U.S.) Food and Drug Administration (FDA) established a final order (OTC000006, issued on 24 September 2021) setting the Over-the-Counter (OTC) sunscreen monograph (M020). On the same date, the FDA issued a proposed order proposing amendments to that monograph, including a proposal that para-aminobenzoic acid (PABA) and trolamine salicylate be found not GRASE (generally recognized as safe and effective) due to safety concerns.

The FDA received over 15,000 public comments on the 2021 proposed order. Rather than delay action pending review of all comments, the FDA chose to finalize the PABA and trolamine salicylate proposals first, issuing Final Order OTC000008-1 on 10 September 2026. The FDA is continuing to work through the remaining provisions of the 2021 proposed order (e.g., labeling, dosage forms, maximum sun protection factor (SPF) levels) and will address them in future order(s).

Unless otherwise disputed, the new final administrative order removing PABA and trolamine salicylate from the monograph shall take effect on 11 September 2027. The FDA states that no sunscreen products currently marketed in the U.S. contain PABA or trolamine salicylate, so this order is not expected to require any market withdrawals or consumer action.

The European Commission adopted on 30 June 2026 and published on 10 September 2026, Commission Delegated Regulation (EU) 2026/1423, amending Part A of Annex I of Regulation (EU) 2019/1021 (the European Union (EU) Persistent Organic Pollutants, POPs Regulation) with respect to chlorpyrifos.

Chlorpyrifos (CAS No. 2921-88-2) is an organophosphate pesticide. It is persistent in the environment, bioaccumulates in wildlife and humans, and is capable of long-range environmental transport, posing risks to ecosystems and human health. At the 12th meeting of the Conference of the Parties (COP12) to the Stockholm Convention, held from 28 April to 9 May 2025 in Geneva, Switzerland, the Parties unanimously agreed to list chlorpyrifos in Annex A of the Convention, with specific exemptions. A public consultation on the EU implementing measure was conducted from 21 November to 19 December 2025.

1. Requirement

The regulation adds chlorpyrifos to Part A of Annex I of the POPs Regulation, prohibiting its manufacture, placing on the market, and use in the EU. It also establishes an unintentional trace contaminant (UTC) limit for chlorpyrifos, in substances, mixtures or articles of 0.01 mg/kg (0.000001% by weight). Products exceeding this limit are not eligible for the UTC exemption under Article 4(1)(b) of the POPs Regulation and risk being prohibited from being placed on the EU market.

2. Exemptions

Unlike other recently listed POPs, no specific exemptions are granted for chlorpyrifos. Because it is not approved as an active substance under the Plant Protection Products Regulation ((EC) No 1107/2009) or the Biocidal Products Regulation ((EU) No 528/2012), companies cannot apply for a transition period or special use authorization for products containing chlorpyrifos.

3. Implementation

The prohibition on manufacturing, importing, exporting, or use of chlorpyrifos takes effect on 30 September 2026 (20 days after publication in the Official Journal).

The European Commission adopted Commission Implementing Decision (EU) 2026/2032, amending Implementing Decision (EU) 2023/740 to update references to harmonized standards under the Toy Safety Directive (Directive 2009/48/EC) on 11 December 2026.

The Decision updates the list of harmonized toy safety standards published in the Official Journal by:

• Adding EN 71-4:2020+A1:2025 (Experimental sets for chemistry and related activities);

• Adding EN 71-15:2025 (Formamide in foam toy materials (content)); and

• Adding EN 71-16:2025 (Certain chlorinated phosphorus flame retardants (TCEP, TCPP, TDCP) in toy materials).

Withdrawal of the earlier version of the EN 71-4 standard

The earlier version, EN 71-4:2020, Experimental sets for chemistry and related activities, will be withdrawn from the list effective 14 March 2028. Until this date, both versions of the standard are harmonized and valid, provided that the applicable conditions are met. Manufacturers may continue to rely on previously listed versions of the standards for presumption of conformity. After this date, only the updated version can be used.