On October 22, 2026, the Governor of Pennsylvania signed Senate Bill 381 (SB 381), which was enacted the same day as Act No. 92 of 2026. SB 381 amends Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes. New Sections 58A21 and 58A22 provide that, with effect from January 1, 2027, a cosmetic that has been developed or manufactured using animal testing performed or commissioned by the manufacturer or any of its suppliers may not be sold or offered for sale in the Commonwealth.
The Act also contains other provisions governing animal experimentation; this article focuses on those relating to cosmetics. CIRS Group has compiled and summarized the key points of the cosmetics-related provisions as follows, for reference.
Legislative Background and Timeline
SB 381 was introduced on March 6, 2025 and referred to the Senate Judiciary Committee. Its passage included the following main milestones:
- On September 10, 2025, the bill passed the Senate on third reading and was finally agreed to by a vote of 50 in favor and 0 against;
- On September 28, 2026, the House Judiciary Committee reported the amended text to the full House for consideration, producing the final printer’s copy, PN 1972;
- On October 19, 2026, the House passed the amended bill by a vote of 203 in favor and 0 against, and the Senate concurred in the House amendments the same day;
- On October 22, 2026, the bill was presented to the Governor and approved, and was enacted as Act No. 92 of 2026.
Key Points of the Cosmetics-related Provisions
In the text finally adopted, the cosmetics-related provisions can be summarized in four respects:
- It sets out key definitions, including those of animal, animal test, cosmetic, ingredient, manufacturer, supplier and medical research;
- It establishes the prohibition on sale and the timing cut-off for animal testing, with January 1, 2027 as the dividing line;
- It lists the circumstances exempted from the prohibition and the conditions applicable to them;
- It designates the enforcement authority and the remedies available, and makes clear that it does not create a private right of action.
Scope of Application and Key Definitions
Pursuant to Section 58A21, the relevant terms are defined as follows:
- Animal: any live vertebrate other than a human being;
- Animal test: the application of a cosmetic or any of its ingredients to any part of the body of an animal, whether by an in vivo or an in vitro method;
- Cosmetic: the definition laid down in Section 321(i) of Title 21 of the United States Code (21 U.S.C. § 321(i)) applies;
- Ingredient: a component of a cosmetic as defined in Section 700.3 of Title 21 of the Code of Federal Regulations (21 CFR 700.3);
- Manufacturer: an entity whose name appears on the cosmetic label in accordance with the requirements of 21 CFR 701.12 (concerning the name and business address of the manufacturer, packer or distributor);
It should be noted that “manufacturer” is determined by the name stated on the label; accordingly, entities whose names appear on the label as distributor or packer also fall within the scope of the obligations.
- Supplier: an entity that provides, directly or through a third party, any ingredient used in the formulation of the manufacturer’s cosmetic;
- Medical research: research relating to the causes, diagnosis, treatment, control or care of physical or mental disease and injury in humans and animals, or research relating to the development of a biological product, device or drug as defined in 21 U.S.C. § 321(g)(1); the term does not include the testing of an ingredient that was formerly used in a drug, that has already been tested by traditional animal methods to characterize the ingredient and establish its safety in humans, and that is now intended for use in a product other than a biological product, medical device or drug.
Prohibition on Sale and Timing Cut-off
Section 58A22(a) provides that a manufacturer may not sell or offer for sale in Pennsylvania any cosmetic that has been developed or produced using animal testing conducted or commissioned by the manufacturer or any of its suppliers on or after January 1, 2027.
Companies must distinguish between two dates:
- January 1, 2027: this is the cut-off date for the conduct of animal testing. Section 58A22(c) further clarifies that animal testing carried out on an ingredient or a cosmetic before that date is not subject to the prohibition, and that the Act does not prevent a manufacturer from continuing to review, evaluate or retain existing animal testing data;
- Effective date of the Act: this is laid down separately in Section 2 of the bill, which provides that the Act takes effect 180 days after enactment. On the basis of signature on October 22, 2026, that date falls on April 20, 2027.
Exemptions
Section 58A22(b) provides that nothing in this section applies to the following:
1. An animal study conducted for the purpose of medical research;
2. A cosmetic developed or manufactured using animal testing that falls within any of the following circumstances:
- The animal testing was required by a federal or State regulatory authority, and all of the following conditions are met: the ingredient requiring animal testing is in widespread use and cannot be replaced by another ingredient; the ingredient poses a specific human health concern, and the need for the animal testing is supported by justification based on a research protocol; and no non-animal test method or strategy for obtaining the relevant data has been accepted by the relevant federal or State regulatory authority;
- The animal testing was carried out outside the United States for the purpose of meeting the requirements of a foreign regulatory authority, and the evidence derived from it has not been used to substantiate the safety of the cosmetic under federal or State law;
- The animal testing was conducted on a product or ingredient subject to the requirements of Chapter V of the Federal Food, Drug, and Cosmetic Act;
- The animal testing was required by a federal, State or foreign regulatory authority for a purpose other than cosmetics. However, evidence derived from animal testing conducted after January 1, 2027 may not be used to establish the safety of a cosmetic under federal or State law unless all of the following are met: for the safety endpoint concerned, no non-animal method or strategy accepted by any federal agency or by the Organisation for Economic Co-operation and Development (OECD) exists; there is documentary evidence of the non-cosmetic intent of the testing; and, prior to reliance on that data, the ingredient has a history of use outside cosmetics of at least one year.
Enforcement and Remedies
Where a person violates this chapter or a rule, regulation or order promulgated under this chapter, the Attorney General may bring a civil action in the Commonwealth Court or in the court of common pleas of the county in which the violation occurred, applying for injunctive relief and such other relief as the court considers appropriate; the commencement of such an action or proceeding does not relieve the party of any penalty or other sanction to which the party is subject under this chapter or under the rules, regulations and orders promulgated thereunder.
In addition, that section also sets out two limitations: the Act does not create a private right of action, and no individual may bring suit independently to enforce these provisions; institutions of higher education and their employees are likewise not subject to civil liability arising under this Act. Accordingly, the enforcement risk faced by companies comes mainly from enforcement actions brought by the Attorney General; neither consumers nor competitors can initiate litigation on this basis.
CIRS Reminder
In light of the provisions of the Act, cosmetics companies intending to sell products in Pennsylvania are advised to carry out compliance self-checks and preparations in advance in the following areas:
- Confirm whether you are an obligated party: this is determined by the name stated on the cosmetic label. Any producer, packer or distributor whose name appears on the label pursuant to 21 CFR 701.12 constitutes a “manufacturer” under the Act, and must assess whether the sale of its products in Pennsylvania falls within the scope of the prohibition.
- Review the supply chain against the January 1, 2027 cut-off: this date is the dividing line for all relevant animal testing (including testing commissioned from third parties), and it is recommended that information be verified with ingredient suppliers to confirm whether any animal testing has been carried out on the relevant ingredient or cosmetic on or after January 1, 2027.
- Prepare the supporting materials for the exemptions: relying on an exemption under the Act requires supporting information, covering the feasibility of substituting the ingredient, an explanation of the testing concerned, a review of non-animal methods, the purpose of any overseas testing, and the history of use of the ingredient in other fields, and it is recommended that such documentation be compiled and retained before the cut-off date.
What Can CIRS Do for You
Established in 2007, the CIRS Group is a leading product safety and regulatory consulting firm. CIRS has branch offices in the Republic of Ireland, South Korea, the United States, the United Kingdom, Japan, and China. CIRS Group utilizes its technical expertise, various resources, and international network to provide one-stop compliance services, from regulatory compliance and laboratory testing to R&D and data services across multiple industries. This includes chemicals, cosmetics, food and food beverages, medical devices, agrochemical products, disinfectants, and consumer goods. It helps clients gain a competitive advantage by reducing business risks associated with regulatory affairs.
The CIRS cosmetic team provides expert support to ensure that cosmetic products meet stringent global cosmetic regulations and safety standards.
We offer comprehensive, lifecycle-based solutions for personal care products, from early-stage cosmetic ingredient development through to final product registration. Our services include:
- Cosmetic ingredient development and regulatory strategy,
- Physical/chemical and analytical tests,
- Toxicological tests (in vivo & in vitro),
- Efficacy and claim substantiation studies (in vivo & in vitro), and
- Ingredient and product registration across global markets.
With deep expertise in cosmetic regulatory compliance and safety evaluations, our team enables brands to bring products to market efficiently and with confidence.
Our Services
- The United States Agent
- The United States FDA Cosmetic Facility Registration
- The United States FDA Cosmetic Product Listing
- The United States FDA OTC Drug Registration
- The United States Color Additive Batch Certification
- The United States Cosmetic/OTC Drug Labeling Review
- International Cosmetic Ingredient Name (INCI) Application
If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.
Further Information
