标准简介
加州第 65 号提案，正式名称为《1986 年安全饮用水和有毒物质执行法案》，要求企业在故意使个人接触加州已知会导致癌症、出生缺陷或其他生殖危害的化学物质之前，提供「清晰合理」的警告。由环境健康危害评估办公室（OEHHA）管理，第 65 号提案目前列出了 900 多种化学物质。与传统产品安全法规不同，第 65 号提案是一项知情权法律——它不禁止产品或设定最大限值，而是要求在暴露超过「安全港」水平时发出警告。尽管是加州州法律，第 65 号提案实际上影响所有向加州消费者销售产品的企业，使其成为事实上的全国和国际合规要求。
第 65 号提案合规涉及两种主要方法：测试产品以确认所列化学物质低于安全港水平（致癌物的无显著风险水平，生殖毒物的最大允许剂量水平），或提供合规的警告标签。自 2018 年 8 月起，新的警告法规要求特定的措辞、至少识别一种所列化学物质，以及 P65Warnings.ca.gov 网站的链接。该法律主要通过私人诉讼执行——「赏金猎人」律师和组织可以起诉未能提供适当警告的企业，每次违规每天最高罚款 2,500 美元。这种私人执法机制使第 65 号提案比其他产品安全法律更具攻击性。常见受影响的产品类别包括食品和饮料、电子产品、家具、化妆品、膳食补充剂和建筑材料。对于国际卖家来说，第 65 号提案通常是最令人意外的合规要求，因为它可能适用于完全符合 EPA、FDA 和欧盟化学品安全法规的产品。
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.