2013/39/EU (Article 8b) foresees establishing a “watch list” of new substances of
concern for which new monitoring data need to be gathered (sic) “for the purpose of
supporting future prioritization exercises in accordance with article 16(2) of the
WFD.” Hence, the inclusion of a substance in the “watch list” might be regarded as a
necessary (but not sufficient) condition to its final incorporation into the list of
priority substances. The European Commission, on the other hand, in art. 8c of the
aforementioned Directive 2013/39/EU entitled “Specific provisions for pharmaceutical substances”, undertakes to carry out a specific study on the risks posed by
medicinal products in the environment and developing within the next 2 years a
strategic approach to pollution of water by pharmaceutical substances. The final
outcomes of such approach are available in the corresponding document issued by
the European Commission [17].
Up to now the list of priority substances does not include any pharmaceutical
substance. Contrastingly, several of them have been already added in the “watch
list,” in their two successive versions (Table 1). The compounds included are three
estrogenic natural or synthetic hormones and five antibiotics belonging to three
different families (three macrolides, one penicillin, and one quinolone). It is worth
mentioning the case of the NSAID diclofenac that appeared in the first watch list but
was finally withdrawn from the second one. A new “watch list” is currently under
preparation led by the JRC (Ispra, Italy), but at the time of writing this book chapter,
only a preliminary draft is available [20]. Notably, this document incorporates new
pharmaceuticals as proposed candidate substances, namely, the antifungals
Table 1 Pharmaceutical substances included in the “watch list” according to Decision (EU) 2015/
495 and Decision (EU) 2018/840
Substance
CAS
Therapy class
Remark
17-Alpha-ethinylestradiol
(EE2)
57-63-6 Synthetic
hormone
Included in Decision (EU) 2015/
495 [18]
17-Beta-estradiol (E2)
50-28-2 Hormone
Included in Decision (EU) 2015/
495 [18]
Estrone (E1)
53-16-7 Hormone
Included in Decision (EU) 2015/
495 [18]
Erythromycin
114-07-8 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Azithromycin
83905-01-5 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Clarithromycin
81103-11-9 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Amoxicillin
26787-78-0 Penicillin
antibiotic
Included in Decision (EU) 2018/
840 [19]
Ciprofloxacin
85721-33-1 Quinolone
antibiotic
Included in Decision (EU) 2018/
840 [19]
Diclofenac
15307-86-5 NSAID
Included in Decision (EU) 2015/
495 [18]
Withdrawn in Decision (EU) 2018/
840 [19]
14
N. Montemurro et al.
concern for which new monitoring data need to be gathered (sic) “for the purpose of
supporting future prioritization exercises in accordance with article 16(2) of the
WFD.” Hence, the inclusion of a substance in the “watch list” might be regarded as a
necessary (but not sufficient) condition to its final incorporation into the list of
priority substances. The European Commission, on the other hand, in art. 8c of the
aforementioned Directive 2013/39/EU entitled “Specific provisions for pharmaceutical substances”, undertakes to carry out a specific study on the risks posed by
medicinal products in the environment and developing within the next 2 years a
strategic approach to pollution of water by pharmaceutical substances. The final
outcomes of such approach are available in the corresponding document issued by
the European Commission [17].
Up to now the list of priority substances does not include any pharmaceutical
substance. Contrastingly, several of them have been already added in the “watch
list,” in their two successive versions (Table 1). The compounds included are three
estrogenic natural or synthetic hormones and five antibiotics belonging to three
different families (three macrolides, one penicillin, and one quinolone). It is worth
mentioning the case of the NSAID diclofenac that appeared in the first watch list but
was finally withdrawn from the second one. A new “watch list” is currently under
preparation led by the JRC (Ispra, Italy), but at the time of writing this book chapter,
only a preliminary draft is available [20]. Notably, this document incorporates new
pharmaceuticals as proposed candidate substances, namely, the antifungals
Table 1 Pharmaceutical substances included in the “watch list” according to Decision (EU) 2015/
495 and Decision (EU) 2018/840
Substance
CAS
Therapy class
Remark
17-Alpha-ethinylestradiol
(EE2)
57-63-6 Synthetic
hormone
Included in Decision (EU) 2015/
495 [18]
17-Beta-estradiol (E2)
50-28-2 Hormone
Included in Decision (EU) 2015/
495 [18]
Estrone (E1)
53-16-7 Hormone
Included in Decision (EU) 2015/
495 [18]
Erythromycin
114-07-8 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Azithromycin
83905-01-5 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Clarithromycin
81103-11-9 Macrolide
antibiotic
Included in Decision (EU) 2018/
840 [19]
Amoxicillin
26787-78-0 Penicillin
antibiotic
Included in Decision (EU) 2018/
840 [19]
Ciprofloxacin
85721-33-1 Quinolone
antibiotic
Included in Decision (EU) 2018/
840 [19]
Diclofenac
15307-86-5 NSAID
Included in Decision (EU) 2015/
495 [18]
Withdrawn in Decision (EU) 2018/
840 [19]
14
N. Montemurro et al.