標準簡介
加州第 65 號提案，正式名稱為《1986 年安全飲用水和有毒物質執行法案》，要求企業在故意使個人接觸加州已知會導致癌症、出生缺陷或其他生殖危害的化學物質之前，提供「清晰合理」的警告。由環境健康危害評估辦公室（OEHHA）管理，第 65 號提案目前列出了 900 多種化學物質。與傳統產品安全法規不同，第 65 號提案是一項知情權法律——它不禁止產品或設定最大限值，而是要求在暴露超過「安全港」水準時發出警告。儘管是加州州法律，第 65 號提案實際上影響所有向加州消費者銷售產品的企業，使其成為事實上的全國和國際合規要求。
第 65 號提案合規涉及兩種主要方法：測試產品以確認所列化學物質低於安全港水準（致癌物的無顯著風險水準，生殖毒物的最大允許劑量水準），或提供合規的警告標籤。自 2018 年 8 月起，新的警告法規要求特定的措辭、至少識別一種所列化學物質，以及 P65Warnings.ca.gov 網站的連結。該法律主要透過私人訴訟執行——「賞金獵人」律師和組織可以起訴未能提供適當警告的企業，每次違規每天最高罰款 2,500 美元。這種私人執法機制使第 65 號提案比其他產品安全法律更具攻擊性。常見受影響的產品類別包括食品和飲料、電子產品、家具、化妝品、膳食補充劑和建築材料。對於國際賣家來說，第 65 號提案通常是最令人意外的合規要求，因為它可能適用於完全符合 EPA、FDA 和歐盟化學品安全法規的產品。
900+ Listed Chemicals
The Proposition 65 list contains over 900 chemicals known to the State of California to cause cancer, birth defects, or other reproductive harm — updated at least annually.
Point-of-Sale Warnings
Businesses must provide "clear and reasonable" warnings before exposing anyone in California to listed chemicals — on product labels, shelf tags, websites, or in-store signage.
Bounty Hunter Enforcement
Unique private enforcement mechanism allows any individual to file lawsuits on behalf of the public. This has led to thousands of lawsuits annually, predominantly by private plaintiffs.
list_alt Key Requirements
- Warning obligation for listed chemical exposures
- Safe harbor levels (NSRLs and MADLs) for specific chemicals
- Clear and reasonable warning requirements (Article 6)
- Short-form and long-form warning options
- Internet and catalog sales warning requirements
- Discharge prohibition into drinking water sources
- Annual listing updates by OEHHA
- Burden on business to prove exposure is below safe harbor
Who Needs to Comply?
Any business with 10 or more employees that operates in California or sells products to California consumers. This includes manufacturers, distributors, retailers, and online sellers — regardless of where the business is physically located.
Key Requirements
Chemical Assessment
Determine whether your product contains any of the 900+ Proposition 65 listed chemicals. Consider all routes of exposure — ingestion, inhalation, and dermal contact during normal and reasonably foreseeable use.
Exposure Assessment
Quantify consumer exposure levels and compare against safe harbor levels (No Significant Risk Levels for carcinogens, Maximum Allowable Dose Levels for reproductive toxicants). If exposure is below safe harbor, no warning is required.
Warning Requirements
Provide clear and reasonable warnings using compliant methods — product labels, shelf tags, signs, or website notices. Warnings must include the triangular warning symbol, the word "WARNING," and identify at least one listed chemical.
Record Keeping
Maintain documentation supporting your warning decisions or safe harbor determinations. Records should include testing data, exposure calculations, and chemical analysis to defend against potential lawsuits.
Penalties & Enforcement
Civil penalties up to $2,500 per day per violation. Most enforcement comes through private lawsuits (bounty hunter provisions), where settlements average $50,000-$100,000 for small businesses. Attorney fees for plaintiffs are also recoverable.