What It Is

CE Marking (Conformité Européenne) is the EU's mandatory conformity marking for products under harmonised legislation like directives and regulations. It signifies the manufacturer's declaration that the product meets essential health, safety, and environmental requirements. The primary scope covers categories such as electrical equipment, machinery, and medical devices. It uses a risk-based approach via conformity assessment modules (A-H) and harmonised standards for presumption of conformity.

Key Components

• Essential requirements from specific legislation (e.g., LVD, RED, MDR).
• Conformity modules: self-assessment (Module A) or Notified Body involvement.
• Technical documentation, EU Declaration of Conformity (DoC), and CE affixation.
• Post-market surveillance under Regulation (EU) 2019/1020. Self-declaration model for low-risk products; third-party certification for high-risk.

Why Organizations Use It

Mandated for EEA market access, enabling free movement. Reduces trade barriers, ensures compliance liability, and builds trust. Manages risks via documented evidence, avoids fines/recalls, and supports tenders in regulated sectors.

Implementation Overview

Map applicable legislation, perform risk assessment, compile technical file, issue DoC, affix mark. Applies to manufacturers/importers in EEA-impacted industries. Varies by product risk; Notified Body audits for high-risk. Timeline 6-12 months typical.

What It Is

The Clean Air Act (CAA), codified at 42 U.S.C. §7401 et seq., is a comprehensive U.S. federal statute regulating air emissions from stationary and mobile sources. Its primary purpose is protecting public health and welfare through ambient air quality standards and technology-based controls, using cooperative federalism where EPA sets national floors and states implement via plans and permits.

Key Components

• NAAQS for six criteria pollutants (ozone, PM, CO, Pb, SO2, NO2) with primary/secondary standards.
• SIPs/FIPs, NSR/PSD permitting, NSPS, NESHAPs/MACT.
• Title V operating permits consolidating requirements.
• Market-based programs (Title IV acid rain trading) and Title VI ozone protection. Built on health-based ambient targets and source emission limits; compliance via permits, no formal certification but audited enforcement.

Why Organizations Use It

• Mandatory for emitters exceeding thresholds to avoid penalties, sanctions.
• Manages enforcement risks (fines, shutdowns, citizen suits).
• Enables permitting agility, ESG benefits, operational efficiency.
• Builds stakeholder trust through transparent reporting.

Implementation Overview

Phased approach: gap analysis, permitting (Title V/NSR 6-18 months), install controls/monitoring (CEMS/PEMS), training, ongoing audits. Applies to major sources/industries nationwide; state variations require tailored strategies. (178 words)