1 Open Public Consultation Results
1.3 Detailed analysis
1.3.18 Question 22: Are there specific requirements in the EU legislative framework which
1.3.18.1 Analysis of closed question responses
Respondents could answer, ‘yes’, ‘no’ or ‘don’t know’ to this question. There were 285 responses in total to the question. The results are shown in Table 1-53. The table shows that the majority of respondents from Group 1 (61% or 17) and Group 2 (70% or 123), plus 47% (21) of those from Group 4 replied ‘don’t know’, perhaps reflecting that this question specifically asks about costs to authorities. The majority of Group 3 respondents (representing government or public authorities) (56% or 20) did answer ‘yes’, that there are specific requirements in the EU legislative framework that lead to particularly significant costs for authorities. There are also 19% (7) of Group 3 respondents that answered ‘no’ and a further 15% (9) who responded ‘I don’t know’.
Table 1-53: Extent to which respondents agreed that there are specific requirements in the EU legislative framework that lead to significant costs (n=285)
Response
Group 1 (citizens) (n=28)
Group 2 (industry)
(n=176)
Group 3 (public authority)
(n=36)
Group 4 (NGO/others)
(n=45)
No. % No. % No. % No. %
Yes 5 18% 46 26% 20 56% 17 38%
No 6 21% 7 4% 7 19% 7 16%
I don’t know 17 61% 123 70% 9 25% 21 47%
1.3.18.2 Analysis of open text responses
Respondents who answered yes to the closed question were asked to explain what these costs are.
In total 32 comments were reviewed. The key themes from these comments have been extracted and are summarised in Table 1-54. The table also shows which groups the comments were from.
Table 1-54: requirements in the legislative framework that lead to significant costs for authorities themes from non-questionnaire responses (n=32; Group 1 (citizens) = 2, Group 2 (industry) = 18, Group 3 (public authority) = 6, Group 4 (NGO/others) = 6)
Theme By
Themes on resource needs (burden)
Consequences of classification and lack of scientific validity result in long
disputes leading to major costs for authorities Group 1 (citizen)
Missing harmonised regulations causes costs for authorities Group 3 (public authority) Group 2 (industry)
Labour costs Group 3 (public authority)
Training costs Group 3 (public authority)
Group 2 (industry) Understanding and keeping up to date with changes in legal requirements Group 3 (public authority) Implementation and compliance (inspection) costs
Group 3 (public authority) Group 2 (industry) Group 4 (NGO/others)
Reporting requirements Group 3 (public authority)
Effective market surveillance Group 2 (industry)
System for market surveillance is ineffective and inefficient Group 4 (NGO/others)
Registration and authorisation under REACH Group 2 (industry)
Group 4 (NGO/others)
National nanomaterial registers Group 2 (industry)
Group 4 (NGO/others)
Seveso requirements Group 2 (industry)
Burden placed on competent authorities to implement 1272/2009 for PPPs1
caused numerous problems on resources Group 2 (industry)
Huge administrative burdens for authorities Group 4 (NGO/others)
Cost of cleaning up pollution Group 4 (NGO/others)
Themes on potential for cost savings
Identification of hazardous properties and legal classification by competent
authorities would save costs Group 3 (public authority)
Binding criteria should be established regarding implementation of new and
complex methods Group 3 (public authority)
Complete declaration of all ingredients on packaging would be desirable Group 3 (public authority)
Duplication of testing costs Group 3 (public authority)
Tendency to charge companies for compliance inspections Group 2 (industry) Better implementation of polluter pays principle is needed Group 4 (NGO/others) Extended producer responsibility should be included across chemical
legislation to displace the economic burden of recycling, clean-up and regulation
Group 4 (NGO/others) Themes on enforcement
No specific themes Other themes
Table 1-54: requirements in the legislative framework that lead to significant costs for authorities themes from non-questionnaire responses (n=32; Group 1 (citizens) = 2, Group 2 (industry) = 18, Group 3 (public authority) = 6, Group 4 (NGO/others) = 6)
Theme By
Product families are more attractive as an instrument to industry than
authorities Group 3 (public authority)
Drinking Water Directive sets quality standards that take no account of the
variation in chemical properties of 484 substances approved as pesticides in EU Group 2 (industry) Notes: 1 PPPs = Plant Protection Products. 2 SME = Small and Medium-sized Enterprises
1.3.18.3 Themes from analysis of sample of non-questionnaire responses
As well as the responses from the OPC, an analysis was made of the themes from nine other responses that were received. Table 1-55 provides a summary of the themes from these non-questionnaire responses.
Table 1-55: requirements in the legislative framework that lead to significant costs for authorities themes from non-questionnaire responses (n=9)
Theme By
Themes on resource needs (burden)
Implementation of legislation is resource-intensive Group 2 (industry)
BPR1 requirements are over-burdensome Group 2 (industry)
Authorisation costs can push businesses out of Europe Group 2 (industry) Compliance costs with Seveso III Directive put financial and administrative
squeeze on business and affect EU competitiveness Group 2 (industry) There is a cost linked to the implementation of legislation Group 2 (industry) There is also a cost associated with the “perception” of the substance,
mixture by users/buyers further down in the supply chain and some blacklisting, purely driven by hazard whilst there may be no risk and/or the risk is controlled
Group 2 (industry)
The testing for higher tiers is completely focussed on the reconfirmation of negative evidence by a higher testing requirement. Such a system is very inefficient and leads to large amounts of higher tier vertebrate tests with a low level of positive responses
Group 2 (industry)
Themes on enforcement
SMEs2 must also be subject to legislation and even to the same standard of
protection for human health and the environment Group 3 (public authority) Enforcement might be much more efficient, for measures that are aiming
at ensuring level playing fields and market restrictions to be organized at EU level
Group 2 (industry) Other themes
Polluter pays principle need to be applied more widely Group 3 (public authority) Notes: 1 BPR = Biocidal Products Regulation.
1.3.18.4 Comparison of themes
The themes associated with the specific requirements of the EU chemicals legislative framework that lead to costs for authorities are summarised in the table below. Here the themes focus on the types
of costs that have been identified. Note the count is the number of comments that were attributed to each theme, not the number of respondents. This means one respondent could be counted more than once in the sample if, for example, they made comments that were used in two or more themes.
Table 1-56: Comparison of responses on specific requirements of EU chemicals legislative framework that leads to particularly significant costs for authorities
Non-questionnaire responses OPC responses
Type of cost Themes from Type of cost Themes from
Themes on fees and costs for authorities Implementation of
legislation
Group 2 (3) Implementation of legislation
Group 3 (1) Group 2 (7) Group 4 (1)
Compliance costs Group 2 (1) Compliance costs
Authorisation costs Group 2 (1) Authorisation costs and reporting requirements
Group 3 (1) Group 2 (2) Group 4 (1) Perception of hazard Group 2 (1) Missing harmonised
regulations Market surveillance Group 2 (2) National registers for
Key: Group 4 captures non-governmental organisation (NGO), consumer association, trade association, trade union, academia or a research or educational institute, other from Question 5 of the OPC
Table 1-56 shows the types of costs identified by respondents. Specific comments on causes of these costs and their likely significance include:
Costs associated with implementation and compliance:
o Plant Protection Products: The so-called “unless-clause” in the uniform principles for the decision-making in the framework of the authorisation of PPP opens the floodgates to an excessive use of more and more complex and extensive higher tier methods by the applicants in their dossiers. This has led to a considerable increase in the expenditure of the competent authorities in the risk assessment, partly exceeding the limits of their capacity (Group 3);
o RoHS exemption renewals and applications consume a significant amount of resources and time for authorities because of the nature of open scope under current RoHS legislation (Group 2);
o The implementation of chemicals control legislation is time- and resource-intensive, also for authorities. Many of the smaller or less economically robust Member States are lacking in the resources needed for review, evaluation, and implementation. The stronger Member States in the EU become disproportionately burdened (Group 2);
o There are substantial costs to the enforcement agencies within the Member States, several of which are related to unnecessary bureaucratic and or administrative burdens, especially with regards to reporting duties (Group 3);
o Chemical data needs to be reported to numerous authorities due to numerous requirements. (ECHA, Commission (ozone depleting substances…), National Authorities for workers safety, Seveso, environment, VOC, fluorinated gases…) This leads to costs for both enterprises and authorities (Group 2);
o Risk assessments are very costly, especially when the burden of proof is on authorities and not on industry. A change in this would ease the burden for authorities and be in line with the polluter pays principle (Group 3).
Costs associated with market surveillance:
o Meaningful inspection regimes to ensure legislation is properly and reasonably applied requires staff who are scientifically and technically competent in the industry being regulated…Example - for Water Framework Directive, significant skills are required in sampling, sample management followed by analytical capability and capacity (Group 2);
o Proper and exhaustive market surveillance and enforcement of existing requirements to be able to stop all (or a majority of) dangerous toys entering the EU market would certainly be costly for authorities (Group 2);
o Inspections of undertakings require a good knowledge of the regulation and its interpretation and the time to analyse the procedures in place (Group 2, translated);
o The current market surveillance system is ineffective and inefficient and the EU must urgently unblock the product safety and market surveillance package to create an EU-based and more harmonised system which equips market surveillance authorities with better financial and human resources (Group 4);
o Very high sophisticated and too detailed regulation like e.g. RoHS are very difficult for being crosschecked. Enforcement of regulations for less than one microgram inside an electronic component is requiring enormous effort in analytics (Group 2).
Potential for cost savings:
o Avoidable duplication of testing as lack of crop protection agents and biocides European legal mechanisms for the regulation of substances (Group 3, translated);
o A better implementation of the polluters pay principle is needed. A good example to follow is the Toxics Use Reduction Act from Massachusetts, which obliges users of SVHC to pay a fee which is used by authorities to help reducing the use of SVHC.
This act has successfully reduced the emission of hazardous substances to the environment as well as the generation of hazardous waste while supporting local companies (Group 4);
o The extended producer responsibility should be included across chemical legislation to displace the economic burden of recycling, clean-up costs and regulation on the chemical industry. The extended producer responsibility already exists in the Batteries (Directive 2006/66/EC), where producers are responsible for financing waste battery collection and recycling (Group 4).